Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
FDA Recall #Z-0716-2014 — Class II — December 19, 2013
Product Description
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Reason for Recall
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.
Recalling Firm
Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
52
Distribution
US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Code Information
Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated