Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicate

FDA device recall Z-0364-2014 · posted 2013-11-19 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.

Action taken

Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.

Root cause

Device Design

Status

Terminated

Product code

MBI

Quantity affected

25

Distribution

USA Nationwide Distribution in the states of VA, CA, Ky, and IN

Date initiated

2013-10-10

Date posted

2013-11-19

Date terminated

2014-07-16

Location

Warsaw, IN

Related 510(k) clearances