Biomet, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0716-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

Product Classification:

Class II

Date Initiated: December 19, 2013

Date Posted: January 22, 2014

Recall Number: Z-0716-2014

Event ID: 67142

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.

Status: Terminated

Product Quantity: 52

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.

Voluntary or Mandated:

Voluntary: Firm initiated