CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
various polyethylene implants Sports Med Repicci II Tibial recalled
Zimmer Biomet is recalling various polyethylene implants Sports Med Repicci II Tibial Components, distributed nationwide in the US. The recall was initiated on 17 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1863-2017
- FDA event ID
- 76507
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2017
- FDA classified
- 18 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 17 Feb 2017 | Recall initiated by company | |
| 18 Apr 2017 | Classified by FDA | +60 days |
| 26 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Product as listed by the FDA
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Where it was distributed
Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
Questions about this recall
Is various polyethylene implants Sports Med Repicci II Tibial Components recalled?
Yes. Zimmer Biomet recalled various polyethylene implants Sports Med Repicci II Tibial Components on 17 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1863-2017.
Why was it recalled?
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Which lots are affected?
Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150
Where was it sold?
Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |