Biomet: Medical Device Recall in 2020 - (Recall #: Z-2362-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235

Product Classification:

Class II

Date Initiated: May 1, 2020

Date Posted: June 24, 2020

Recall Number: Z-2362-2020

Event ID: 85641

Reason for Recall:

Device and tray that houses the device did not pass steam sterilization process validation testing

Status: Terminated

Product Quantity: 136 units

Code Information:

All lots

Distribution Pattern:

Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND

Voluntary or Mandated:

Voluntary: Firm initiated