FDA recall Z-0837-2018

Stryker Corporation · Class II · device

Product

STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

Reason for recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

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-0837-2018