Recall Z-1841-2016 ยท GDZ Handle, Scalpel
Integra York PA, Inc
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
| Date | May 31, 2016 (initiated Mar 11, 2016) |
| Status | Terminated |
| Reason | One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle. |
| Root cause | Nonconforming Material/Component |
| Action | Integra mailed out an Urgent: Voluntary Medical Device Recall letter to customers informing them to evaluate their inventory for the affected product. If product was shipped to customers, they were asked to identify their customers and to stop shipping immediately. Integra requested that customers complete the attached form that was sent with the notification indicating whether or not they had the affected product on hand and customer service will contact them to provide a Return Authorization number for the product's return. Customers could reach Customer Service at 866-854-8300. |
| Quantity | 678 Chisel Blade Holders |
| Distribution | Worldwide distribution. US nationwide, Mexico, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.