—#122873

Product

Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K123485
Affected lot / code info: Catalog:110003173, Lot 127480, 185420, 233500, 233520

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2013-10-10
Posted by FDA: 2013-11-19
Terminated: 2014-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122873. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.