Tibial Component Modular — Class II medical device recall Z-1380-2022
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2022-07-20, distributed in AL, CA, FL, GA, IL, IN, KS, MI…. There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This ma
| Recall number | Z-1380-2022 |
|---|---|
| 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 | 2022-05-24 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA |
| Countries outside the US | AE, AR, AT, AU, BE, BG, CA, CH, CN, CO, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HU, ID, IL, IN, IT, LT, LV, MX, NL, NO, PE, PH, PK, PL, RO, SA, SE, SI, SK, TH, TR, UA, VN |
| Quantity | 3,785 |
| UPC / GTIN / UDI-DI | 04026575370870, 04026575370887, 04026575370894 |
| Lot numbers | 151116/4741, 210222/0789, 210308/0020, 210308/0035 |
Product
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Reason for recall
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
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-1380-2022. 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.