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Knee Replacement Recalls

Knee replacement recalls have been issued because of loosening, early wear or faulty packaging. Nearly 1,000 implant parts used in knee surgeries have been affected by DePuy, Zimmer-Biomet and Stryker knee replacement recalls. Lawsuits blame manufacturers for selling defective devices.

The advocacy group Consumers Union reviewed the FDA’s medical device database and found that 708 knee replacement recalls were issued between 2003 and 2018. Drugwatch conducted a separate review in 2018 and identified another 76 recalls. Roughly 97 percent of all recalls during that timeframe involved knee replacements from just three manufacturers: Zimmer-Biomet, DePuy and Stryker.

The recalls included nearly 250,000 package and label issues, knee implant parts and tools used in knee replacement surgery from 2014 through 2017 alone.

Smith & Nephew recalled more than 42,000 Journey I BCS Knee Systems in 2018 after joint registries in the United Kingdom and Australia — which collect data on joint replacement surgeries to improve patient care — reported the device’s revision surgery rates were 1.5 times that of the average for all knee replacements.

Manufacturers and Knee Replacement Safety

Knee implant manufacturers are responsible for appropriate marketing of their products. They must warn consumers and health care professionals about their devices’ risks.

Manufacturers are also responsible for monitoring their products for problems after FDA approval. But critics argue that the FDA approval process does not do enough to keep unsafe devices off the market.

Manufacturers often rely on the agency’s Premarket Notification process. This is also called the 510(k) process.

It lets knee replacement makers skip more rigorous tests. They only have to show their device is “substantially equivalent” to similar products.

Knee replacement lawsuits blame manufacturers for selling defective devices.

Reasons for Knee Replacement Recalls

Manufacturers issue knee replacement recalls for several reasons. These can be as simple as faulty packaging on knee replacement parts. Or they can involve defective parts that pose a risk of serious injuries.

Knee Replacement Recall Issues
Faulty design
Implants and tools were prone to fracture. Tools had flawed designs or sometimes fell into the surgical site
Improper fit
Implants could suffer damage when surgeons forced a component into place
Patients needed revision surgery because knee replacements loosened
Early wear
Parts wore out sooner than expected
Packaging errors
Faulty packages compromised surgical tools’ sterility
Co-mingled components
Parts of the left and right knee replacements became mixed together. This caused confusion during surgery
knee replacement recall
Premature knee replacement loosening can lead to infection, inflammation and pain.

Manufacturers with the Most Knee Replacement Recalls

Three manufacturers account for the majority of knee replacement recalls since 2003.

DePuy Synthes accounted for almost half of the total recalls.

Two other companies combined for only 19 recalls between them.

Knee Recalls by Manufacturer, 2003 - 2018
Knee Replacement Manufacturer Knee Recalls
DePuy Synthes 485
Zimmer Biomet* 355
Stryker 125
Smith & Nephew 15
Wright Medical** 4
Percentage of Knee Replacement Recalls, 2003 - 2018
*Combines recalls by both Zimmer and Biomet before the companies merged in 2015.
**Wright sold off its hip and knee replacement business in 2016. It no longer makes knee replacement implants.

DePuy Knee Replacement Recalls

DePuy Synthes has issued hundreds of recalls over the years.

One of the most recent was in December 2017 for Sigma knee components. The devices had higher than expected failure rates.

DePuy also recalled almost 14,000 Attune knee surgical tools in 2015. But to date, there have been no recalls of Attune Knee implants.

The FDA’s database shows at least six other DePuy knee replacement recalls since 2013.

Between 2003 and 2013, DePuy issued at least 477 knee replacement-related recalls. That’s more than any other knee implant manufacturer.

DePuy Knee Implant-Related Recalls
Date Amount Device Type Reason
December 2017 7,500 SIGMA HP PFJ Cemented Trochlear Implants Elevated revision rates
January 2016 351 SIGMA HP MBT Non-Keel Punch Knee Instruments Design flaw that could cause a delay in surgery
September 2015 7,488 Specialist 2 Intramedullary (SP2 IM) Rod Instrument fracturing during surgery and leaving parts of the rods in patients
June 2015 13,964 Attune Knee Tibial Articulation Surface Instruments Could come off during surgery, leaving a part in device in the patient
March 2015 28,732 LCS Complete RPS Inserts Reports of higher revision surgery rates in Australia
November 2014 7,944 Attune Intuition Impaction Handle Reports of fractures potentially leaving parts in the patient
November 2014 4,555 Attune Intuition Impactors Could fracture and pieces could be left in the patient
February 2014 129 S-ROM Noiles Rotating Hinges Defective packaging could compromise sterility

Zimmer Biomet Knee Replacement Recalls

Zimmer Biomet has issued at least 355 knee replacement-related recalls since 2003.

One of the most recent was in 2017 for more than 28,000 joint components. Inspections found elevated endotoxin levels on the parts.

Zimmer Biomet is the largest knee-implant maker in the world. The company took on its present form with the merger of Zimmer and Biomet in 2015.

Recent Zimmer Biomet Knee Replacement Recalls
Date Units Device Type Reason
November 2017 13,227 Gender Solutions Patello-Femoral Joint System Packaging problems
November 2017 1023 Persona Partial Knee instruments Spacer blocks do not fit in the alignment tower instrument or handle
October 2017 430 Persona Partial Knee Spacer Blocks Problems with flexion in range-of-motion trials
February 2017 28,000 Zimmer Biomet polyethylene joint components Elevated endotoxin levels
January 2017 15,000 Vanguard Total Knee System Mislabeling and packaging problems
May 2016 10,256 Persona Trabecular Metal Tibial Plate Knee implants Implant loosening
January 2016 42,064 Zimmer NexGen Knee implants Packaging could adhere to implant parts

Stryker Knee Replacement Recalls

There have been 125 Stryker knee replacement recalls since 2003.

Stryker voluntarily recalled its ShapeMatch Cutting Guides after patients reported injuries. These instruments were meant to help surgeons position the Stryker Triathlon knee implant before the bone was cut, but complaints submitted to the FDA allege the device was misaligned, which caused such complications as joint instability, chronic pain and revision surgery. The FDA later classified it as a Class I recall in April 2013.

In 2016, the company issued two recalls affecting 14,000 surgical instruments.

Stryker Components or Tool Related Recalls:
Date Amount Device Type Reason
August 2016 2,039 Stryker Orthopaedics Patella Assembly Instruments Parts could come apart from an accompanying instrument during surgery
June 2016 12,469 Modular Handle Triathlon Instruments Parts could come apart from the rest of the instrument
September 2015 3,444 MIS Modular Distal Capture Triathlon Instruments Reports that parts could come apart from the instruments
August 2014 1,147 Triathlon Femoral Components Packaging issue could affect the shelf life of the devices’ sterility
August 2014 1,147 Scorpio Femoral Components Packaging issue could affect the shelf life of the devices’ sterility
April 2013 7,868 ShapeMatch Cutting Guide Device misalignment could result in knee implants being placed in the wrong position

Smith & Nephew Knee Replacement Recalls

Smith and Nephew has announced 15 knee replacement-related recalls since 2003.

The 2018 recall of the Journey I BCS Knee System affected more than 42,000 units, according to the FDA.

The following Journey I BCS femoral component products were named in the recall:
  • JOURNEY BCS CoCr Femoral Component
  • JOURNEY BCS Oxinium Femoral Component
  • JOURNEY BCS Tibial Insert

Previous Smith & Nephew recalls involved fewer than 100 total units.

Smith & Nephew Components or Tool Related Recalls:
June 2018 42,050 Journey I BCS Knee System Higher than normal revision rates because of early component loosening and other problems
May 2017 46 Legion Tib Cone Impactor Heads The wrong adhesive used in assembly
March 2016 24 TC-Plus Primary Tibial Components Manufacturing defect; it could make the polyethylene insert difficult or impossible to seat during surgery
January 2016 8 Legion Hemi Stepped Tibial Screw-On Wedges Screws were too long

Wright Medical Knee Replacement Recalls

Wright Medical announced four knee replacement recalls since 2003. Drugwatch found none after 2013.

Wright sold its hip and knee division to Corin Orthopaedics in 2016 for a reported $290 million.

Wright is no longer a major player in the knee-implant business.

Arthrex Inc. Knee Replacement Recalls

Arthrex has issued two recalls related to its iBalance knee replacement line: one for the iBalance Total Knee Arthroplasty System and another for the iBalance Unicondylar Knee Arthroplasty System.

Arthrex, Inc. Knee Implant Component Recalls:
Date Amount Device Type Reason
December 2015 2,378 Arthrex iBalance TKA Tibial Tray Outer metal surface was smooth compared to previous textured components
October 2017 20 iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL Incorrect part number printed on label

Please seek the advice of a medical professional before making health care decisions.

Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By
Emily Miller
Emily Miller Managing Editor
Medically Reviewed By
Dr. Aimee V. Hachigian-Gould
Dr. Aimee V. Hachigian-Gould Orthopedic Surgeon

19 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

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  9. Consumers Union. (2013, September 9). A Summary of Knee Recalls Consumers Union Safe Patient Project. Retrieved from
  10. U.S. Food and Drug Administration. (2013, February 22). Class 1 Device Recall LPS Diaphyseal Sleeves Retrieved from
  11. U.S. Food and Drug Administration. (2017, January 28). Class 2 Device Recall Vanguard Total Knee System. Retrieved from
  12. Smith & Nephew. (2017). Annual Report 2016. Retrieved from:
  13. Zimmer Biomet. (2017, February 17). Medical Device Recalls. Retrieved from:
  14. Sheffield, M. (2016, October 24). Wright Medical Sells Hip/Knee Division. Memphis Business Journal. Retrieved from:
  15. FDA. (n.d.). Medical Device Recalls (Accessed May 9, 2018). Retrieved from:
  16. U.S. Food and Drug Administration. (2015, December 17). Class 2 Device Recall Arthrex IBalance TKA Tibial Tray. Retrieved from
  17. U.S. Food and Drug Administration. (2017, October 3). Class 2 Device Recall iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL. Retrieved from
  18. U.S. Food & Drug Administration. (2019, April 9). Class 2 Device Recall Journey BCS Knee System. Retrieved from
  19. Smith & Nephew. (2018, June 13). Urgent Field Safety Notice. Retrieved from
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