Z-2732-2024 Class II Ongoing

Recalled by Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
September 4, 2024
Initiation Date
August 5, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit (OUS only)

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.

Distribution Pattern

International distribution to the country of Australia.

Code Information

Catalog Number: C-MM100434-00; Lot Number: HX2H9A;