Device product
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Z-1506-2020
Product summary
- Event
- Event 84252
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)
- Official record key
device-enforcement:Z-1506-2020
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 #: DS-0024 Lot #s: 2018022801 2018050801
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.