Stem Extractor f/Guide Bar recall
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Why was Stem Extractor f/Guide Bar recalled?
There is a potential for the connection screw of the stem extractor to break.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949
- Product
- Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
- Recalling firm
- Synthes, Inc.
- Quantity
- 31
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)