Z-1438-2012

REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet...

Name: Z-1438-2012 REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet...
Creator: Biomet, Inc.
Published: 2012-03-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-03-20 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head... on 2012-03-20. The reason FDA records is "Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1438-2012
Status: Terminated
Initiated: 2012-03-20
Posted: 2012-04-19
Terminated: 2013-02-07
Recalling firm: Zimmer GmbH
Product: REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and measured against print specifications.
Root cause tag: design
FDA root cause: Component design/selection
Action: Biomet sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to continue monitoring implanted patients for disassociation of the pin component and report to Biomet. The Alert included a complete listing of device invoice history and patient information (if supplied). Contact the firm for confirmation of receipt of the notice and for questions at 574-372-3983.
Quantity in commerce: 64 units distributed
Distribution: Distributed in California and Pennsylvania.
Product codes and lots: Catalog number: CP113456 with lot numbers: 593310, 743610, 750120, 815030, and 815040.

Product code KRO

K083779Class IIMak Oss Knee Femoral ComponentsBiomet Manufacturing Corp / cleared 2009-04-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)