Recall Z-2246-2018— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2018-03-05, terminated 2020-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set. Reason: Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-05
- Terminated
- 2020-02-28
- Firm location
- West Chester, PA, United States
Product description
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Reason for recall
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Data sourced from openFDA. This site is unofficial and independent of the FDA.