FDAJune 9, 2015device
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implan...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
What to do
FDA enforcement status: Terminated
Brands named
omnilife scienceomnilife
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAArtelon FlexBand Plus Ref: 41054 & 410572026-02-06
- FDAArtelon FlexBand Dynamic Matrix Ref: 310572026-02-06
- FDAFemiClear Daily Bladder Strength Dietary Supplement, 28 Count, UPC 817008020684, SKU FEM500602025-09-04
- FDA4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)2025-07-30
- FDABZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-012025-07-22
- FDABD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD2025-07-08
- FDABD Trucount Controls, 30 Test - REF: 3403352025-07-08
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