Locking Cortical Screw 3.5mmX38mm recall
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Why was Locking Cortical Screw 3.5mmX38mm recalled?
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
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?
Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
- Product
- Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- Recalling firm
- Biomet, Inc.
- Quantity
- 52
- Distribution
- US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)