FDA recall Z-2244-2018

Stryker GmbH · Class II · device

Product

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Reason for recall

Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm

Distribution

AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX

Key facts

Status
Terminated
Initiation date
2018-05-04
Report date
2018-06-27
Termination date
2020-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Selzach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2018