Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in
FDA device recall Z-2076-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- PIONEER SURGICAL TECHNOLOGY, INC.
- Reason for recall
- Lack of Sterility Assurance
- Action taken
- On 6/11/14 and 6/12/14 the firm contacted their two consignees and surgeon via phone and explained that the product did not go through the sterilization process. The returns authorization number and shipping labels were discussed for the unused unit. On 6/18/14 and 6/20/14 an URGENT: MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION was sent to the customers as well as the one surgeon. The letter explained the sterility concerns and that the productis being recalled. Contact Dan Nelson, Manager of Quality, at 906-226-4489 if you have any questions or concerns.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 5
- Distribution
- US Nationwide Distribution in the states of TX and FL
- Date initiated
- 2014-06-11
- Date posted
- 2014-07-17
- Date terminated
- 2014-10-22
- Location
- Marquette, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRITIUM STERNAL CABLE PLATE SYSTEM (K133785) | Pioneer Surgical Technology, Inc. | 2014-01-27 |