Endo Model M Tibial Components Modular Knee Prosthesis System — Class II medical device recall Z-2410-2024
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2024-07-24, distributed nationwide. Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to i
| Recall number | Z-2410-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany |
| Recall initiated | 2024-05-22 |
| Classified | 2024-07-18 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CN, CO, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HU, ID, IL, IN, IT, KE, LT, LU, MX, NL, NO, PE, PL, RO, SA, SE, SI, SK, TH, UA, UY, VN |
| UPC / GTIN / UDI-DI | 04026575034727, 04026575034734, 04026575034741, 04026575034758, 04026575164028, 04026575164035, 04026575164042, 04026575164059, 04026575316007, 04026575316014, 04026575316021, 04026575316038, 04026575316052, 04026575316069, 04026575316076, 04026575316083, 04026575316243, 04026575316281, 04026575316298, 04026575316304, 04026575316557, 04026575316564, 04026575316571, 04026575316588, 04026575316595 and 19 more |
Product
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
Reason for recall
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
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-2410-2024. 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.