Custom Orthopedic Surgical Implant Does Not Match Design Specifications
A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a patient-specific surgical implant that does not match the intended design specifications. The rubric defines risk-of-harm products without reported injury as High (3), which applies here: the mismatch creates potential for surgical complications, but no illnesses or injuries have been reported.
Plain-English summary
Howmedica Osteonics Corp. has recalled a patient-specific, custom-made orthopedic surgical implant component (GMRS Extension Piece, 40MM LEFT, 35-degree extension, Catalog Number C-MM100434-00, Lot HX2H9A). The recalled unit was distributed internationally to Australia.
The device supplied did not match the design proposal for which it was custom-manufactured. This mismatch between the intended design and the device actually provided poses a risk that the implant may not function as designed during or after surgical placement.
The recall affects a single unit that was intended for a specific surgical procedure. Patients or healthcare providers who received this device should contact their surgeon or healthcare provider immediately to verify whether this specific device was used and to discuss any necessary follow-up actions or device replacement.
The recalled product
- Product
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: C-MM100434-00
- Lot Number: HX2H9A
Distribution
Distribution scope not specified by the agency.
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