FDADecember 21, 2021device
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
What to do
FDA enforcement status: Ongoing
Brands named
howmedica osteonicshowmedica
UPCs
07613327013306
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDA1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;2025-08-28
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- FDAMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 2090632024-08-07
- FDACustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;2024-08-05
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