Z-2146-2012 Class II Terminated
FDA device recall Z-2146-2012 was initiated by Encore Medical, Lp on Jul 16, 2012 and is designated Class II. Reason for recall: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw… The recall status is terminated (terminated Dec 4, 2012). Affected quantity: 18 devices.
Recall details
- Product Type
- Devices
- Report Date
- Aug 15, 2012
- Initiation Date
- Jul 16, 2012
- Termination Date
- Dec 4, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 devices
Product description
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Reason for recall
One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
Distribution pattern
Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Code information
Lot 007A1037, Ref 010-55-25.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2146-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026