SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the a

FDA device recall Z-2316-2015 · posted 2015-07-30 · Terminated

Recall details

Recalling firm

Symmetry Surgical, Inc.

Reason for recall

Lack of sterility assurance.

Action taken

The firm initiated their recall by via US certified mail, with return receipt requested, beginning on 06/18/2015. The Urgent Medical Device Recall letter, dated June 16, 2015, identified the affected product, as well as the reason for the recall. The letter discussed the potential harm associated with the issue, and requested that the consignees examine their inventory and discontinue use immediately. Customers should promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted lots. Symmetry Surgical Customer Service should be contacted with questions or any other needs.

Root cause

Package design/selection

Status

Terminated

Product code

HXD

Quantity affected

2,708 units

Distribution

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.

Date initiated

2015-06-16

Date posted

2015-07-30

Date terminated

2016-05-26

Location

Antioch, TN