Home / Recalls / Symmetry Surgical, Inc. / Z-2316-2015

Z-2316-2015 Class II Terminated

Recalled by Symmetry Surgical, Inc. — Antioch, TN

FDA device recall Z-2316-2015 was initiated by Symmetry Surgical, Inc. on June 16, 2015 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated May 26, 2016). Affected quantity: 2,708 units.

Recall Details

Product Type: Devices
Report Date: August 5, 2015
Initiation Date: June 16, 2015
Termination Date: May 26, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,708 units

Product Description

SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.

Code Information

149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.