Reported Dec 4, 2019 · Terminated
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement |
| 2 | Tumor resections |
| 3 | Revision of previously failed total joint arthroplasty |
| 4 | Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use. |
- Lot codes and dates
- All lots manufactured
- between January 2008 - May 2019
931 of 931 codes
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(01)00880304554924(17)230121(10)793680 (01)00880304554924(17)230128(10)032450 (01)00880304554917(17)230115(10)793670 (01)00880304554832(17)230107(10)927940 (01)00887868346934(17)230107(10)927940R (01)00880304554832(17)230306(10)423630 (01)00887868346934(17)230306(10)423630R (01)00880304554832(17)230325(10)684490 (01)00880304554870(17)230121(10)793540
- Amount recalled
- 219988 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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