FDA recall Z-1241-2018

Product

AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

Reason for recall

Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-01-30

Report date

2018-04-04

Termination date

2023-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2018