CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
various polyethylene implants Extremities, Shoulders recalled
Zimmer Biomet is recalling various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System, 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-1859-2017
- 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
- Other Medical Devices
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 Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow 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
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 113870 361800 Item 113951 605610 684300 684310 684320 684330 684340 Item 113952 174480 241520 292440 292480 372590 372600 372610 372620 372630 372640 596930 596940 596950 596960 605640 605650 605670 Item 113954 174560 241500 270220 270230 292490 292510 292520 292560 292570 372650 372660 372670 372680 372700 372710 596970 596980 596990 605680 605690 605700 605710 707650 Item 113956 292580 292590 292640 605720 605730 605740 Item 114827 804070 Item EP-115393 488700 488710 577700 577710 667420 667430 667460 Item EP-115394 488750 577740 Item EP-115395 577760 Item EP-115396 488760 577770 Item EP-115398 832600 Item PM555411 430360 Item XL-115363 169490 179400 488780 488790 488810 488830 488850 488870 488890 488900 488910 488920 515590 560180 560210 667480 667490 667500 667510 744780 744810 773080 Item XL-115364 542280 542290 744850 744870 Item XL-115366 502530 502540 502560 614450 666000 Item XL-115367 630520
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 76507This product is part of a recall event; the main page for the event is various polyethylene implants Sports Med Repicci II Tibial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | various polyethylene implants Sports Med Repicci II Tibial recalled | Zimmer Biomet | Other | Nationwide | |
| CLASS II | various polyethylene implants Knees Revision Tibial Tray recalled | Zimmer Biomet | Other | Nationwide | |
| CLASS II | various polyethylene implants BIO PLUG recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide | |
| CLASS II | various polyethylene implants Hips Active Articulation recalled | Zimmer Biomet | Other | Nationwide | |
| CLASS II | various polyethylene implants Custom parts recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Spinal Rod Cutter recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide |
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| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D. recalled | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
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