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Recall Observatory FDA recall evidence

Device product

Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.

Z-1546-2013

February 14, 2013

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 64424
Status
Terminated
Classification
Class II
Quantity
344 Units
Official record key
device-enforcement:Z-1546-2013

Official wording

Reason: The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.

Code information: Part number 00-0965-002-01

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.

Field note

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