Recall Z-1514-2018— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2018-03-19, terminated 2019-04-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.. Reason: There is a potential for the connection screw of the stem extractor to break..
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-19
- Terminated
- 2019-04-11
- Firm location
- West Chester, PA, United States
Product description
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Reason for recall
There is a potential for the connection screw of the stem extractor to break.
Data sourced from openFDA. This site is unofficial and independent of the FDA.