“Howmedica Osteonics Custom Device Recall: Design Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54310-howmedica-osteonics-custom-device-recall-design-mismatch-risk. Based on FDA recall #Z-2732-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2732-2024%22&limit=1).
Howmedica Osteonics Corp. recalled one Custom Made Device - GMRS EXTENSION Piece on Aug. 5, 2024, because the supplied device did not match the design proposal for a surgical procedure, according to the FDA.
The hazard is that a patient-specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include Howmedica Osteonics recalls acetabular inserts with UHMWPE material aged over 5 years (July 30, 2026), Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include ConMed Suture Anchor Recall (July 14, 2026), Straumann Custom Abutment AS Ti Recall (March 17, 2026), and Straumann GM Helix Dental Implant Recall (July 13, 2026).
How to tell if you have this one
Check for catalog number C-MM100434-00 or lot number HX2H9A on the device. This custom device was made for a specific patient's surgery.
Brand
Howmedica Osteonics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Howmedica Osteonics directly for guidance on next steps.
How this recall unfolded
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2732-2024 (August 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2732-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.