FDAFebruary 6, 2024device
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
What to do
FDA enforcement status: Ongoing
Brands named
waldemar link gmbh co kg mfg sitewaldemarwaldemar link
UPCs
040265753355720402657533558904026575335596040265753356020402657533561904026575335626040265753356330402657533564004026575335657040265753356640402657533567104026575335688
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 duo. Material Number: 66057897.2026-03-25
- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;2026-02-11
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;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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