Recall Z-0813-2018 ยท LRY Punch, Surgical
Alto Development Corp
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
| Date | Oct 23, 2017 |
| Status | Terminated |
| Reason | Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility. |
| Root cause | Package design/selection |
| Action | A&E Medical sent an Recall Notice Action Required letter dated October 20, 2017. Surgical Punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in a loss of sterility. Recent testing identified certain shipping configurations which may cause damage to the sterile barrier pouch if the Surgical Punches experience excessive movement from multiple drops during transport A&E is recalling all product currently on the market. Customer and Distributor Letters were sent with Acknowledgement Form. Product will be quarantined pending rew |
| Quantity | 411,486 units |
| Distribution | Worldwide Distribution - USA Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.