FDA recall Z-0838-2018

Product

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

Distribution

Distributed domestically to . Distributed internationally to Australia and Mexico.

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2018-03-14

Termination date

2024-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0838-2018