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Recall Observatory FDA recall evidence

Device product

Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

Z-0695-2013

October 25, 2012

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 63863
Status
Terminated
Classification
Class II
Quantity
476 units
Official record key
device-enforcement:Z-0695-2013

Official wording

Reason: Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.

Code information: Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.

Distribution pattern: Nationwide Distribution, including the states of PA, OH, NY, CA and IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.