Compress — Class II medical device recall Z-0519-2020
Terminated recall by Zimmer Biomet, Inc., reported 2019-12-04, distributed nationwide. Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
| Recall number | Z-0519-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-08-21 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CO, CR, EC, IN, IT, JP, KR, MX, MY, NL, NZ, PA, SG, SV, TH, TT, TW, VE |
| Quantity | 219,988 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00880304260320, 00880304430259, 00880304461727, 00880304461734, 00880304468351, 00880304468375, 00880304508903, 00880304508910, 00880304508927, 00880304508934, 00880304508941, 00880304508958, 00880304508965, 00880304508972, 00880304508989, 00880304508996, 00880304509009, 00880304509016, 00880304509023, 00880304509030, 00880304509047, 00880304509054, 00880304509061, 00880304509078, 00880304509085 and 15 more |
| Model numbers | 178350, 178351, 178352, 178353, 178354, 178354S, 178355, 178356, 178357, 178358, 178359, 178360, 178361, 178362, 178363, 178364, 178365, 178366, 178367, 178368, 178369, 178370, 178371, 178372, 178373 and 24 more |
Product
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 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.
Reason for recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0519-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.