Recall Z-0364-2014 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
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.
| Date | Nov 19, 2013 (initiated Oct 10, 2013) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| Quantity | 25 |
| Distribution | USA Nationwide Distribution in the states of VA, CA, Ky, and IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF Biomet Sports Medicine, Mar 18, 2013 |