23.5 Deg Rasp Handle Assy- LEFT Nonsterile recall
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
Why was 23.5 Deg Rasp Handle Assy- LEFT Nonsterile recalled?
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
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?
Item Number 82-0167-636-00 Lot Number 97009530, 97009782
- Product
- 23.5 Deg Rasp Handle Assy- LEFT Nonsterile
- Recalling firm
- Zimmer, Inc.
- Quantity
- 412 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
- Recall date
- August 20, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)