FDA recall Z-1667-2022

Product

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

Reason for recall

Some of the devices did not pass fatigue testing.

Distribution

Distribution was made to NJ. There was no military/government distribution.

Key facts

Status

Terminated

Initiation date

2022-07-12

Report date

2022-09-07

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cirencester, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1667-2022