—#105036

Product

Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.

FDA product code: HXK — Holder, Needle; Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K860018
Affected lot / code info: Catalog: 8180-50-006, Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.

Why it was recalled

DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.

Root cause (FDA determination)

Component change control

Action the firm took

On 11/9/2011 DePuy sent "Medical Device Recall Notice" letters to Distributors and to direct account hospitals. Recall notices included instructions to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN via distributors and sales representatives. The product is going to be discontinued and no reconditioning or reworking for the product is planned. For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - pm EST.)

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-11-08
Posted by FDA: 2012-01-11
Terminated: 2013-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105036. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.