Recalls / —

—#107270

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.

FDA product code

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K083779

Affected lot / code info

Catalog number: CP113456 with lot numbers: 593310, 743610, 750120, 815030, and 815040.

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

Distributed in California and Pennsylvania.

Timeline

Recall initiated

2012-03-20

Posted by FDA

2012-04-19

Terminated

2013-02-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #107270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.