Z-0139-2013 Class II Terminated
FDA device recall Z-0139-2013 was initiated by Encore Medical, Lp on Sep 28, 2012 and is designated Class II. Reason for recall: A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there… The recall status is terminated (terminated Jan 25, 2013). Affected quantity: 1 unit.
Recall details
- Product Type
- Devices
- Report Date
- Oct 31, 2012
- Initiation Date
- Sep 28, 2012
- Termination Date
- Jan 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product description
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Reason for recall
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
Distribution pattern
Nationwide Distribution only to CA.
Code information
Model Number 10-55-025, Lot Number 006A1057.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0139-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026