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Terminated

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.

FDA Recall Z-2316-2015 · Posted 2015-07-30

Recalling FirmSymmetry Surgical, Inc.
Recall StatusTerminated
Product CodeHXD
Date Initiated2015-06-16
Date Terminated2016-05-26
Product Quantity2,708 units

Reason for Recall

Lack of sterility assurance.

Firm Action

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

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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