Device product
DS-0022 QUICK START DISTRACTION SCREW 12MM 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-1505-2020
Product summary
- Event
- Event 84252
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)
- Official record key
device-enforcement:Z-1505-2020
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-0022 Lot #s: 2017111301 2018031401
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.