Recall Z-2732-2024— Howmedica Osteonics Corp.
Class II · Ongoing
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2024-08-05. It names 2 FDA 510(k) clearances: K222056, K023087. Product: Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;. Reason: A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-05
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
- K023087 — GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Reason for recall
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.