Pro-Dex Inc: Device Recall
Recall #Z-0280-2025 · 09/23/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0280-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Pro-Dex Inc
- Status
- Ongoing
- Date Initiated
- 09/23/2024
- Location
- Irvine, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2000
Reason for Recall
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Product Description
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Distribution Pattern
US distribution to FL only.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.