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Recall Observatory FDA recall evidence

Device product

Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set

Z-2247-2018

March 05, 2018

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 79754
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-2247-2018

Official wording

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

Code information: H340372

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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