Recall Z-1984-2014 ยท HWC Screw, Fixation, Bone
Synthes, Inc.
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
| Date | Jul 2, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label. |
| Root cause | Labeling design |
| Action | An urgent medical device recall notice, dated May 29, 2014, was sent to end users and sales consultants to advise them of the issue and provide instructions for returning affected devices. |
| Quantity | 44 |
| Distribution | Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.