Recall Z-2399-2012 ยท LRY Punch, Surgical
Biomet, Inc.
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.
| Date | Sep 17, 2012 (initiated Aug 14, 2012) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| Quantity | 62 |
| Distribution | Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.