FDAMay 24, 2022device
Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
waldemar link gmbh co kg mfg sitewaldemarwaldemar link
UPCs
040265753592020402657535921904026575359226
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPediatric care bed; Product Designation: KayserBett IDA;2026-05-04
- FDABrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction w...2026-04-16
- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAHeraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
- FDAEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;2026-02-11
- FDAEndo-Model Replacement Plateau; Item Number: 15-2835/12;2026-01-12
- FDAEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;2026-01-12
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