FDA-Device2018-06-27Class II

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

Synthes (USA) Products LLC

Hazard

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

Sold states

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

Affected count

Manufactured in

1301 Goshen Pkwy, N/A, West Chester, PA, United States

Products

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

Official notice

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

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