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Recall Observatory FDA recall evidence

Device product

1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

Z-0467-2014

October 25, 2013

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 66761
Status
Terminated
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-0467-2014

Official wording

Reason: Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.

Code information: 510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405

Distribution pattern: Nationwide Distribution including states: AL, GA, IL, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.