RecallRadar

FDA Device recall Z-1574-2016

5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile

On 2016-05-04 the FDA classified a Class II recall of 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile by Synthes Usa Products, citing 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 ex….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1574-2016
ClassificationClass II
Statusterminated
Initiated2016-04-04
Published2016-05-04
Last updated2026-09-13 11:54 UTC
CompanySynthes Usa Products
DistributionIL, IN

Product

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

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.

Identifiers

code_infoLot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1574-2016%22

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