Recall Z-3109-2011 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
| Date | Aug 31, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| Reason | The device packaging was punctured by the device, resulting in loss of implant sterility. |
| Root cause | Package design/selection |
| Action | 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 r |
| Quantity | 4925 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR Biomet, Inc., Mar 4, 2011 |