Recall Z-0381-2014 ยท FZX Guide, Surgical, Instrument
Biomet, Inc.
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
| Date | Nov 22, 2013 (initiated Oct 25, 2013) |
| Status | Terminated |
| Reason | Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip. |
| Root cause | Nonconforming Material/Component |
| Action | 10/25/2013 Urgent Medical Device Recall Notifications were sent to each Distributor and Risk/Recall Manager at each direct account identifying the recalled device, possible adverse health consequences and instructing consignees to immediately locate and remove devices from circulation, following instructions on the FAX back form and returning it within 3 business days to FAX 574-372-1683 and returning product to Biomet Return Goods, 56 East Bell Drive Warsaw In 46580. Questions should be directed to 574-372-1570 M-F, 8 a.m. to 5 p.m. |
| Quantity | 1130 |
| Distribution | Worldwide Distribution: USA (nationwide) and Internationally to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.