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Recall Observatory FDA recall evidence

Device product

Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

Z-1523-2015

March 18, 2015

Class II

Product summary

Firm
Zimmer Gmbh
Event
Event 70993
Status
Terminated
Classification
Class II
Quantity
30 units
Official record key
device-enforcement:Z-1523-2015

Official wording

Reason: Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.

Code information: Lot Number(s): 13870129 & 13878179.

Distribution pattern: Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.