Recall Z-1857-2017— Smith & Nephew, Inc.

Name: FDA recall Z-1857-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-09

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-03-09, terminated 2019-08-21. It names one FDA 510(k) clearance: K132296. Product: D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424. Reason: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Terminated: 2019-08-21
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K132296 — D-RAD SMART PACKSmith & Nephew, Inc.·cleared 2014-01-07

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

D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424

Reason for recall

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

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