Device product
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Z-0716-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 67142
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52
- Official record key
device-enforcement:Z-0716-2014
Official wording
Reason: 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.
Code information: Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Distribution pattern: US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Derived failure modes
-
Unknown
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.