Device product
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Z-2146-2012
Product summary
- Event
- Event 62561
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 devices
- Official record key
device-enforcement:Z-2146-2012
Official wording
Reason: 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.
Code information: Lot 007A1037, Ref 010-55-25.
Distribution pattern: Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Derived failure modes
-
Labeling or packaging
mislabeling