—#110399

Product

JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.

FDA product code: LRY — Punch, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: REF. 912064 LOT 121040, 497540, 839530

Why it was recalled

Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.

Root cause (FDA determination)

Device Design

Action the firm took

Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return via fax to 574-372-1683. Questions related to the recall should be directed to 574-371-3758, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.

Timeline

Recall initiated: 2012-08-14
Posted by FDA: 2012-09-17
Terminated: 2013-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110399. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.