Endo Model SL Tibial Components 16-2817/02 Tibial Component — Class II medical device recall Z-2411-2024

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-2411-2024`
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	`04026575359202`, `04026575359219`, `04026575359226`, `04026575370870`, `04026575370887`, `04026575370894`

Product

Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm

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-2411-2024. 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.