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Terminated

djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

FDA Recall Z-2146-2012 · Posted 2012-08-06

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHWC
Date Initiated2012-07-16
Date Terminated2012-12-04
Product Quantity18 devices

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.

Firm Action

DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255. For questions regarding this recall call 512-832-9500.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.

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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