Encore Medical, Lp: Medical Device Recall in 2012 - (Recall #: Z-2146-2012)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2012.
Data Source: FDA.
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
Product Classification:
Class II
Date Initiated: July 16, 2012
Date Posted: August 15, 2012
Recall Number: Z-2146-2012
Event ID: 62561
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.
Status: Terminated
Product Quantity: 18 devices
Code Information:
Lot 007A1037, Ref 010-55-25.
Distribution Pattern:
Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Voluntary or Mandated:
Voluntary: Firm initiated