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
- Company
- Pro-Dex Inc
- Recall Initiated
- September 23, 2024
- Posted
- October 31, 2024
- Recall Number
- Z-0280-2025
- Quantity
- 2000
- Firm Location
- Irvine, CA
Reason for Recall
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Distribution
US distribution to FL only.
Lot / Code Info
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Root Cause
Component design/selection
Action Taken
On 9/23/24, an "URGENT" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following: 1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use. 2) Product should be returned to the recalling firm. 3) The Recall Acknowledgement and Return Form should be completed and returned via email to Recall@Pro-Dex.com or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or Recall@Pro-Dex.com