Z-0508-2012

Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External...

Name: Z-0508-2012 Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External...
Creator: DePuy Orthopaedics, Inc.
Published: 2011-11-08
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2011-11-08 / Terminated

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2011-11-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0508-2012
Status: Terminated
Initiated: 2011-11-08
Posted: 2012-01-11
Terminated: 2013-03-07
Recalling firm: Depuy Orthopaedics Inc.
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.
Product code: HXK Holder, Needle; Orthopedic
Reason for recall: 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.
FDA root cause: Component change control
Action: 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.)
Quantity in commerce: 890
Distribution: Nationwide Distribution
Product codes and lots: Catalog: 8180-50-006, Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.

Product code HXK

K860018Class IFischer Wire/pin ClampBuckman Co., Inc. / cleared 1986-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)