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Recall Observatory FDA recall evidence

Device product

DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

Z-0092-2015

October 02, 2014

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 69432
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0092-2015

Official wording

Reason: Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

Code information: Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.

Distribution pattern: US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.