Exactech Ergo Impactor Handle Recalled for Component Dislodgement
Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for serious harm during surgical use, but no reported illnesses or injuries. The dislodgement hazard meets the High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling the Ergo Impactor Handle (Catalog #321-09-05), a surgical instrument used in orthopedic procedures. A total of 784 devices with various lot numbers are subject to this recall.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. This component failure could compromise the safety and proper functioning of the device during surgical use.
The recalled devices were distributed to 26 US states, Puerto Rico, Australia, France, and Japan. Affected lot numbers include 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, 400798002, 401819005, 401819007, 401819008, 404552002, 405492002, 405253003, and 406041001.
Healthcare providers and facilities that received these devices should contact Exactech, Inc. immediately to arrange device inspection or replacement. The FDA advises reviewing the recall details and following the manufacturer's instructions.
The recalled product
- Product
- Exactech Ergo Impactor Handle, Catalog #321-09-05.
- Manufacturer
- Exactech, Inc.
- Hazard
- component-dislodgement
- mechanical-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog #321-09-05 - Lot numbers: 147544002
- 275151004
- 275151005
- 275151006
- 314934001
- 400107002
- and 400798002
Distribution
Distributed in 26 states:
- AR
- CA
- CO
- FL
- GA
- HI
- ID
- IL
- IN
- KS
- KY
- LA
- MD
- ME
- MN
- NH
- NV
- NY
- OH
- OK
- PA
- PR
- SC
- TN
- TX
- WI
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