Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
This recall has been terminated (originally issued May 31, 2016).
- Company
- Integra York Pa, Inc
- Recall Initiated
- March 11, 2016
- Posted
- May 31, 2016
- Terminated
- April 17, 2017
- Recall Number
- Z-1841-2016
- Quantity
- 678 Chisel Blade Holders
- Firm Location
- York, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution. US nationwide, Mexico, and Korea.
Lot / Code Info
Catalogue No. 4-405, Lot # 97327
Root Cause
Nonconforming Material/Component
Action Taken
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.