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Recall Observatory FDA recall evidence

Device product

5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.

Z-1574-2016

April 04, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 73770
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-1574-2016

Official wording

Reason: This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.

Code information: Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012

Distribution pattern: Distributed in IL and IN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.