Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2316-2015Class II

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

Symmetry Surgical GmbH / initiated 2015-06-16 / Terminated / root cause: packaging

Symmetry Surgical, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Lack of sterility assurance". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-2316-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Symmetry Surgical GmbH
Product
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.
Product code
HXD Clamp
Reason for recall
Lack of sterility assurance.
Root cause tag
packaging
FDA root cause
Package design/selection
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.
Quantity in commerce
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.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2316-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2316-2015Class IITerminatedVoluntary: Firm initiated