Recall Z-2098-2023 ยท GEY Motor, Surgical Instrument, Ac-Powered
Pro-Dex Inc
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
| Date | Jul 5, 2023 (initiated Feb 15, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | On 2/15/23, a recall notice was sent to a customer asking them to cease distribution and return affected product to the recalling firm. Questions can be directed to 949-769-3200. |
| Quantity | 2000 |
| Distribution | US: FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.