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Recall Observatory FDA recall evidence

Device product

Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

Z-0773-2024

January 03, 2024

Class II

Product summary

Firm
Tornier, Inc
Event
Event 93709
Status
Ongoing
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-0773-2024

Official wording

Reason: The incorrect device is contained in the labeled package.

Code information: Batch lot codes 6714AZ, serial numbers 001 to 050: 6714AZ001, 6714AZ002, 6714AZ003, 6714AZ004, 6714AZ005, 6714AZ006, 6714AZ007, 6714AZ008, 6714AZ009, 6714AZ010, 6714AZ011, 6714AZ012, 6714AZ013, 6714AZ014, 6714AZ015, 6714AZ016, 6714AZ017, 6714AZ018, 6714AZ019, 6714AZ020, 6714AZ021, 6714AZ022, 6714AZ023, 6714AZ024, 6714AZ025, 6714AZ026, 6714AZ027, 6714AZ028, 6714AZ029, 6714AZ030, 6714AZ031, 6714AZ032, 6714AZ033, 6714AZ034, 6714AZ035, 6714AZ036, 6714AZ037, 6714AZ038, 6714AZ039, 6714AZ040, 6714AZ041, 6714AZ042, 6714AZ043, 6714AZ044, 6714AZ045, 6714AZ046, 6714AZ047, 6714AZ048, 6714AZ049, 6714AZ050; GTIN 00846832091614.

Distribution pattern: Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The incorrect device is contained in the labeled package.