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U.S. Department of Health and Human Services

Class 2 Device Recall Battery Pack, KLSSE2000

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 Class 2 Device Recall Battery Pack, KLSSE2000see related information
Date Initiated by FirmSeptember 23, 2024
Date PostedOctober 31, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0280-2025
Recall Event ID 95510
Product Classification Battery, replacement, rechargeable - Product Code MOQ
ProductKLS 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
Code Information Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
FEI Number 2081135
Recalling Firm/
Manufacturer		 Pro-Dex Inc
2361 McGaw Ave
Irvine CA 92614-5831
For Additional Information Contact
800-562-6204
Manufacturer Reason
for Recall		The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
FDA Determined
Cause 2		Component design/selection
ActionOn 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
Quantity in Commerce2000
DistributionUS distribution to FL only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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