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Recall Observatory FDA recall evidence

Device product

ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

Z-2363-2015

May 12, 2015

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 71445
Status
Terminated
Classification
Class II
Quantity
21 units
Official record key
device-enforcement:Z-2363-2015

Official wording

Reason: A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

Code information: Catalog #5901-S-4818, Lot MAC7C14.

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.