Exactech Ergo Impactor Handle recall
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Why was Exactech Ergo Impactor Handle recalled?
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog #321-09-05 - Lot numbers: 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, and 400798002; UDI-DI 10885862557674. Updated data - 01/31/2025: Additional Lot Numbers 401819005 401819007 401819008 404552002 405492002 405253003 406041001
- Product
- Exactech Ergo Impactor Handle, Catalog #321-09-05.
- Recalling firm
- Exactech, Inc.
- Quantity
- 784 devices
- Distribution
- Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.
- Recall date
- July 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)