medical Class II Updated 2018-05-16

Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905604, for so

Recalled Product

Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.


Hazard / Issue

Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: lot 326860, 326880
View official government recall

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