Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
FDA device recall Z-2265-2014 · posted 2014-08-19 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 4
- Distribution
- Distributed in the states of WI and MI.
- Date initiated
- 2014-06-30
- Date posted
- 2014-08-19
- Date terminated
- 2015-12-18
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER (K951304) | Synthes (Usa) | 1995-06-16 |