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Terminated

6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.

FDA Recall Z-0139-2013 · Posted 2012-10-25

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHWC
Date Initiated2012-09-28
Date Terminated2013-01-25
Product Quantity1 unit

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

Firm Action

Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution only to CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K9316656.5 MM CANCELLOUS BONE SCREWEncore Orthopedics, Inc. · 1994-02-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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