8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered h
FDA device recall Z-2359-2015 · posted 2015-08-10 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.
- Action taken
- An urgent notice of medical device recall, dated July 1, 2015, was sent to end users and sales consultants to alert them about the device defect and potential risk to patients. Recipients were asked to complete the verification form and return it along with any affected devices their posession.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 4329
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-07-01
- Date posted
- 2015-08-10
- Date terminated
- 2016-08-26
- Location
- West Chester, PA
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