Recall Z-2316-2015 ยท HXD Clamp
Symmetry Surgical, Inc.
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.
| Date | Jul 30, 2015 (initiated Jun 16, 2015) |
| Status | Terminated |
| Reason | Lack of sterility assurance. |
| 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 contact |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.