Recall Z-0192-2016— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-10-07, terminated 2016-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.. Reason: The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-07
- Terminated
- 2016-08-26
- Firm location
- West Chester, PA, United States
Product description
Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
Reason for recall
The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.