medical Class II Updated 2018-09-05

Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCRE

Recalled Product

QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium


Hazard / Issue

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Issued by

FDA

Affected States: AZ, FL, NH, OH
Lot/Code Info: 1000167017, 1000167829, 1000171360, 1000172321, 1000173866, 1000175689, 1000178993, 1000187364, 1000198471, 1000198472, 1000202431, 1000205662, 1000215879, 1000217675, 1000226524, 1000233194, 1000238414, 1000259405
View official government recall

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