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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2316-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
