Recall Z-0280-2025 ยท MOQ Battery, Replacement, Rechargeable
Pro-Dex Inc
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
| Date | Oct 31, 2024 (initiated Sep 23, 2024) |
| Status | Open, Classified |
| Reason | The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package. |
| Root cause | Component design/selection |
| Action | 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 t |
| Quantity | 2000 |
| Distribution | US distribution to FL only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.