LT DISC ULNA — Class II medical device recall Z-0532-2020
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-0532-2020 |
|---|---|
| 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 | 217,240 |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00880304434295, 00880304434332, 00880304434387, 00880304434448, 00880304434455, 00880304434837, 00880304435056, 00880304435933, 00880304435940, 00880304435957, 00880304435964, 00880304435971, 00880304436008, 00880304436343, 00880304437500 |
| Lot numbers | 014060, 020810, 020980, 021170, 041340, 044090, 050740, 093600, 094000, 094010, 094020, 094590, 094600, 094850, 095380, 095430, 095440, 098150, 098170, 109600, 109610, 109620, 119740, 119800, 129330, 143430, 143470, 143650, 144470, 146740, 172700, 188230, 192120, 202130, 209510, 209730, 217470, 217960, 222580, 254200 and 148 more |
| Model numbers | 114704, 114705, 114706, 114707, 114708, 114709, 114714, 114715, 114716, 114717, 114718, 114719, 114744, 114745, 114746, 114747, 114748, 114749, 114754, 114755, 114756, 114757, 114758, 114759, CP561429 and 12 more |
Product
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement
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-0532-2020. 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.