Recall Z-2265-2014 ยท HWC Screw, Fixation, Bone
Synthes, Inc.
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
| Date | Aug 19, 2014 (initiated Jun 30, 2014) |
| Status | Terminated |
| Reason | A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic. |
| Root cause | Employee error |
| Action | An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or lrynn1@its.jnj.com. |
| Quantity | 4 |
| Distribution | Distributed in the states of WI and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951304 | SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER Synthes (Usa), Jun 16, 1995 |