Recall Z-2146-2012— Encore Medical, Lp

Name: FDA recall Z-2146-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-16

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2012-07-16, terminated 2012-12-04. It names one FDA 510(k) clearance: K931665. Product: djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair. 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..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2012-07-16
Terminated: 2012-12-04
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K931665 — 6.5 MM CANCELLOUS BONE SCREWEncore Orthopedics, Inc.·cleared 1994-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.