REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. Product Usage: The Ju

FDA device recall Z-3109-2011 · posted 2011-08-31 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

MBI

Quantity affected

4925

Distribution

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

Date initiated

2011-07-21

Date posted

2011-08-31

Date terminated

2013-04-26

Location

Warsaw, IN

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