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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Exactech, Inc.: UHMWPE Knee Patella Components Recalled for Packaging Defect

Agency Publication Date: June 18, 2024
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Summary

Exactech, Inc. is recalling various OPTETRAK knee patella replacement components, including the Three Peg, One Peg, Inset, and Advanced Patella models. These medical devices were packaged in vacuum bags that did not meet specifications, which can lead to premature wear of the polyethylene plastic. Consumers should contact their surgeon or healthcare provider to determine if their implant is affected by this recall.

Risk

The out-of-specification vacuum bags may allow oxygen to reach the plastic components, causing the material to degrade over time. This degradation can lead to early device failure, bone loss, or the need for a second surgery to replace the damaged components.

What You Should Do

  1. Verify if you have an OPTETRAK patella implant (Three Peg, One Peg, Inset, or Advanced models) by reviewing your medical records or contacting the surgical facility where your knee replacement was performed.
  2. Check the item numbers and lot numbers provided in the product list against your implant identification card or hospital records to confirm if your specific device is affected.
  3. Consult with your orthopedic surgeon or healthcare provider to discuss the status of your implant and whether any additional monitoring or follow-up imaging is required.
  4. Contact Exactech, Inc. at 2320 Nw 66th Ct, Gainesville, Florida, 32653-1630 for further information regarding this voluntary recall and potential next steps.
  5. Contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action

Contact your healthcare provider or Exactech, Inc. for guidance.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: OPTETRAK Three Peg Patella (26MM, 29MM, 32MM, 35MM, 38MM, 41MM)
Model / REF:
200-02-26
200-02-29
200-02-32
200-02-35
200-02-38
200-02-41
UPC Codes:
10885862039576
10885862039583
10885862039590
10885862039606
10885862039613
10885862039620
Lot Numbers (111):
5881807
5908515
5968530
6007309
6038708
6038717
6066779
6345487
6345502
6358520
6431224
6431231
6551547
6557360
6723682
6734364
6771158
6865729
6910696
6910715
6910718
6910745
6910752
6910779
7017876
5968531
6161207
6383171
6358523
6601196
6910805
6066775
6424212
6431232
7017878
6406114
6601148
6161158
6161182
6470948
6470955
5968547
6004184
6383177
6514106
6551513
6551531
6551534
6601150
6672159
Product: OPTETRAK One Peg Patella (26MM, 29MM, 32MM, 35MM, 38MM, 41MM)
Model / REF:
200-03-26
200-03-29
200-03-32
200-03-35
200-03-38
200-03-41
UPC Codes:
10885862039637
10885862039644
10885862039651
10885862039668
10885862039675
10885862039682
Lot Numbers (99):
6389536
6389549
6389551
6389538
6389540
6389531
6389537
6389529
6389534
6389542
6389545
6711546
6711550
6389547
6389548
6389555
6711540
6276447
6276452
6385318
6385319
6607740
6385323
6385304
6385321
6276446
6276448
6385300
6276442
6385310
6385316
6385325
6607741
7037109
6276425
6276429
6276428
6276433
6276450
6276453
6607760
6276437
6276440
6607751
6607754
6276426
6276445
6276449
6607744
6607759
Product: OPTETRAK Inset Patella (23MM, 26MM, 29MM)
Model / REF:
200-05-23
200-05-26
200-05-29
UPC Codes:
10885862039835
10885862039842
10885862039859
Product: OPTETRAK Advanced Patella 3 Peg Implant (26MM, 29MM, 32MM, 35MM, 38MM)
Model / REF:
200-07-26
200-07-29
200-07-32
200-07-35
200-07-38
UPC Codes:
10885862314260
10885862314277
10885862314284
10885862314291
10885862314307
Lot Numbers (172):
5937497
6015804
6038627
6038629
6038631
6067823
6067835
6067836
6305296
6305298
6305299
6535789
6535803
6535805
6535809
6590076
6645243
6673338
6786230
6786240
6786241
6535796
6535800
6535816
6645242
6786226
6038630
6535815
6645241
6739854
6673345
6535784
6645237
6739847
6786239
6535791
6535797
6535801
6535814
6535813
6535818
6590073
6590075
6535785
6535793
6786235
6786236
6015801
6038621
6038623

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94409
Status: Active
Manufacturer: Exactech, Inc.
Sold By: hospitals; surgical centers; orthopedic clinics
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.