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Recall Observatory FDA recall evidence

Device product

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Z-3309-2024

August 29, 2024

Class II

Product summary

Firm
Tornier, Inc
Event
Event 95245
Status
Ongoing
Classification
Class II
Quantity
38 units
Official record key
device-enforcement:Z-3309-2024

Official wording

Reason: Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

Code information: GTIN 00846832084494, Batch Lot # 1495AY

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.