Recall Z-0139-2013— Encore Medical, Lp

Name: FDA recall Z-0139-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-28

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2012-09-28, terminated 2013-01-25. It names one FDA 510(k) clearance: K931665. Product: 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.. Reason: 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.

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Terminated: 2013-01-25
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

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

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