FDA Recall Terminated

REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.

Recall: Z-3109-2011 · Initiated July 21, 2011

Recall

Recall Number: Z-3109-2011
Event Number: 59366
Firm: Biomet, Inc.
FEI Number: 1825034
Product Code: MBI
Status: Terminated
Root Cause: Package design/selection
Initiated: July 21, 2011
Posted: August 31, 2011
Terminated: April 26, 2013
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989

Description

Reason

The device packaging was punctured by the device, resulting in loss of implant sterility.

Action

Biomet Sports Medicine notified distributor accounts by telephone on July 08, 2011 with instructions to quarantine all lots of the recalled product. Urgent Medical Device Recall Notice letters dated July 21, 2011 were sent to all affected customers. The letter identified the recalled product, problem, and actions to be taken. The customers were instructed to immediately locate and discontinue use of the recalled product. The distributors are advised to communicate this notice to their customers if the recalled products were further distributed. The letter also states that distributors are responsible for the return of the recalled product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Customers were instructed to provide phone confirmation at 800-348-9500, extension 3755 or 3756, when the recall notice is received. Further questions should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8 AM to 5 PM.

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.

Quantity

4925