PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 4, 2016 Initiated: April 4, 2016 #Z-1574-2016

Product Description

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

Reason for Recall

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.

Details

Units Affected
15 units
Distribution
Distributed in IL and IN.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.. Recalled by Synthes (USA) Products LLC. Units affected: 15 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1574-2016.