Z-1505-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 18, 2019
- Termination Date
- January 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide.
Code Information
Item #: DS-0022 Lot #s: 2017111301 2018031401