Recall Z-2098-2023— Pro-Dex Inc
Class II · Ongoing
Class II FDA medical device recall by Pro-Dex Inc, initiated 2023-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver. Reason: Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired..
- Recalling firm
- Pro-Dex Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-15
- Firm location
- Irvine, CA, United States
Product description
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Reason for recall
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
Data sourced from openFDA. This site is unofficial and independent of the FDA.