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Terminated

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.

FDA Recall Z-1241-2018 · Posted 2018-03-05

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodePHX
Date Initiated2018-01-30
Date Terminated2023-05-30
Product Quantity387 units

Reason for Recall

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

Firm Action

The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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