Device product
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Z-1503-2020
Product summary
- Event
- Event 84252
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 boxes (245 individual screws)
- Official record key
device-enforcement:Z-1503-2020
Official wording
Reason: The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Code information: Item #: D-0012 Lot #: 2018011601
Distribution pattern: Worldwide.
Derived failure modes
-
Unknown
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.