Z-1241-2018 Class II Terminated
FDA device recall Z-1241-2018 was initiated by Encore Medical, Lp on Jan 30, 2018 and is designated Class II. Reason for recall: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. The recall status is terminated (terminated May 30, 2023). Affected quantity: 387 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Jan 30, 2018
- Termination Date
- May 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 387 units
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Codes: 183312L03, 200006L01, 224643L01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1241-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026