Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device
FDA device recall Z-0202-2014 · posted 2013-11-13 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
- Action taken
- Synthes sent an Urgent Notice: Voluntary Medical Device Recall Notification letters, dated October 3, 2013, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected lots from stock. For questions call 610-719-5450 or contact your Synthes Sales Consultant.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 2979
- Distribution
- Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
- Date initiated
- 2013-10-03
- Date posted
- 2013-11-13
- Date terminated
- 2016-08-26
- Location
- West Chester, PA
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