Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect
Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.
What this means for you
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 involving a mechanical defect that creates risk of intraoperative complications. No illnesses or injuries have been reported. Per the severity rubric, mechanical defects in risk-of-harm medical devices where no injury has been reported score as High (3).
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling certain modular tibial (shin bone) prosthesis components used in orthopedic joint replacement surgery. Approximately 3,785 units of three models are affected: Model W 16-2817/02 (Small), Model W 16-2817/05 (Medium), and Model W 16-2817/07 (Large).
The recalled components have blind screws that may not be possible to loosen during surgery. If this defect is encountered intraoperatively, it may lead to prolonged surgery or require the surgeon to change the planned surgical approach.
The components were distributed both domestically and internationally. Healthcare providers with these components in inventory should verify their stock against the affected model numbers and serial/lot numbers (201002/1683, 211025/1543, 210202/0275, 210302/0308, 210314/1872, 201002/1687) and follow the manufacturer's guidance regarding replacement or return.
The recalled product
- Product
- Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- screw-defect
- surgical-complication
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 (4)
- UDI-DI: 04026575359202 Small
- W
- 04026575359219 Medium
- 04026575359226 Large
Distribution
Distributed in 15 states:
- AL
- CA
- FL
- GA
- IL
- IN
- KS
- MI
- MN
- NV
- NY
- OH
- TN
- TX
- WA
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