PlainRecalls
FDA Devices Moderate Class II 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.

Reported: April 4, 2018 Initiated: January 30, 2018 #Z-1241-2018

Product Description

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.

Details

Recalling Firm
Encore Medical, Lp
Units Affected
387 units
Distribution
US Nationwide Distribution
Location
Austin, TX

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Encore Medical, Lp. Units affected: 387 units.
Why was this product recalled? ▼
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1241-2018.

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