Recall Z-1574-2016— Synthes (USA) Products LLC

Name: FDA recall Z-1574-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-04-04, terminated 2016-09-02. It names one FDA 510(k) clearance: K041533. 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..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2016-09-02
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K041533 — SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWSSynthes (Usa)·cleared 2004-09-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.