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Recall Observatory FDA recall evidence

Device product

Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992

Z-3252-2018

August 03, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80918
Status
Terminated
Classification
Class II
Quantity
217 units
Official record key
device-enforcement:Z-3252-2018

Official wording

Reason: Expiration date incorrectly listed on the label

Code information: Lot Numbers: 053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050

Distribution pattern: AZ CO FL FL GA LA MA MA MO NY SC TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Expiration date incorrectly listed on the label