Recall Z-0640-2017— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-10-03, terminated 2017-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile. Reason: The peel pouches for the affected reaming rods and extraction hooks are delaminating..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-03
- Terminated
- 2017-07-06
- Firm location
- West Chester, PA, United States
Product description
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Reason for recall
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.