FDA recall Z-2246-2018

Synthes (USA) Products LLC · Class II · device

Product

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set

Reason for recall

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Distribution

Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

Key facts

Status
Terminated
Initiation date
2018-03-05
Report date
2018-06-27
Termination date
2020-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2246-2018