Tibial Prosthetic Component Recall: Blind Screws Cannot Be Loosened Intraoperatively
Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for an orthopedic prosthetic component with a critical operational defect—blind screws cannot be loosened during surgery, potentially requiring procedure modifications. While no adverse events have been reported, this constitutes a risk-of-harm product scenario.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling the Tibial Component Modular, an orthopedic prosthesis used in joint replacement surgery. Three models are affected (W 16-2817/32 for small, W 16-2817/35 for medium, and W 16-2817/37 for large), with approximately 3,785 units distributed.
The defect affects the blind screws of the modular tibial component, which cannot be loosened intraoperatively (during surgery). This limitation may necessitate changes to surgical procedure and extend surgery duration.
The affected prosthetic components were distributed domestically to 15 US states (including California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Texas, and Washington) and internationally to numerous countries. The affected serial/lot numbers are 210308/0020, 210308/0035, 210222/0789, and 151116/4741.
The recalled product
- Product
- Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 3,785
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 04026575370870 Small
- W
- 04026575370887 Medium
- 04026575370894 Large
- Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741
Distribution
Part of a larger recall action
This product is one of 4 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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