Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT Recalled by Howmedica Osteonics Corp. Due to A patient specific, custom-made device was supplied for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Howmedica Osteonics Corp. directly.
Affected Products
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Quantity: 1 unit (OUS only)
Why Was This Recalled?
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Where Was This Sold?
International distribution to the country of Australia.
About Howmedica Osteonics Corp.
Howmedica Osteonics Corp. has 229 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report