FDAJune 4, 2015device
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device may have improper screw hole placement due to inaccurate location of the index line.
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.
- FDAArtelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)2026-02-06
- 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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