Synthes 8.5 MM Medullary Reamer Product Usage: An recall
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes…
Why was Synthes 8.5 MM Medullary Reamer Product Usage: An recalled?
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
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?
Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257
- Product
- Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 2979
- Distribution
- Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
- Recall date
- November 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)