Z-2051-2023Class II

Exactech Ergo Impactor Handle, Catalog #321-09-05

Name: Z-2051-2023 Exactech Ergo Impactor Handle, Catalog #321-09-05
Creator: Exactech, Inc.
Published: 2023-06-05
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2023-06-05 / Open, Classified / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Exactech Ergo Impactor Handle, Catalog #321-09-05 on 2023-06-05. FDA classified it as Class II and gives the reason as "The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2051-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-05
Posted: 2023-06-30
Recalling firm: Exactech, Inc.
Product: Exactech Ergo Impactor Handle, Catalog #321-09-05.
Product code: HWA Impactor
Reason for recall: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued the letters via email to their U.S. agents and OUS on 6/5/2023. The letter explained the reason for recall, risk to health, how to recognize that the device may fail or has failed, the actions being taken by the recalling firm, and the actions to be taken by the customer/user. Regarding the actions being taken by the recalling firm, the letter reported they have implemented a new revision of the impactor handle to eliminate the cause of this event. Upon receipt of the attached Recall Acknowledgement Form, the recalling firm will provide the consignee with new revision parts to replace the recalled devices the consignee has in their inventory. Additionally, the recalling firm updated the Equinoxe Shoulder Operative Techniques to include the statement "WARNING: Do not assemble or disassemble device in the surgical field." The letter contained the links to the two updated operative techniques. Actions to be taken by the customer/user included immediately cease distribution or use of the product and quarantine any of the devices in the consignee's inventory or their customer's inventory and return them back to the recalling firm. The consignee was to provide the recall information to their accounts who may have the product in their possession. The enclosed Recall Inventory Response Form was to be completed and returned to the recalling firm via email. The response form is for the consignee to report they have read and understand the instruction, checked their stock and quarantined inventory, as well as indicating the inventory they are returning, and that they have identified and notified their customers who were shipped or may have been shipped this product.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2050-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30
Z-2051-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)