# FDA recall Z-1379-2022

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2022-05-24.

## Product

Tibial Component.  orthopedic prosthesis. Model Nos:    Small, W	16-2817/02                    Medium, W	16-2817/05                    Large, W	16-2817/07

## 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.

## Distribution

Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA.  Foreign distribution to Algeria  Argentina  Australia  Austria  Belgium  Bulgaria  Canada  China  Colombia  Denmark  Ecuador  Estonia  Finland  France  Germany  Great Britain  Greece  Hungary  India  Indonesia  Israel  Italy  Latvia  Libya  Lithuania  Mexico  Netherlands  Norway  Pakistan  Peru  Philippines  Poland  Romania  Saudi Arabia  Slovakia  Slovenia  Spain  Sudan  Sweden  Switzerland  Thailand  Turkey  Ukraine  United Arab Emirates  Uruguy  Vietnam

## Key facts

- **Recall number:** Z-1379-2022
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-24
- **Report date:** 2022-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norderstedt, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1379-2022

## Citation

> AI Analytics. FDA recall Z-1379-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1379-2022. Source: US FDA. Licensed CC0.

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