3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
FDA device recall Z-0640-2017 · posted 2016-11-19 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- Action taken
- DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 319 units
- Distribution
- Distributed Nationwide
- Date initiated
- 2016-10-03
- Date posted
- 2016-11-19
- Date terminated
- 2017-07-06
- Location
- West Chester, PA
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