Exactech Ergo modular impactor handle may be missing its cross-pin
Exactech is recalling the Equinoxe Ergo Modular Impactor Handle, model 321-09-05, because the impactor handle may be missing a cross-pin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a missing cross-pin in a surgical impactor handle is a defect that could affect its use, and no injuries are stated in the source.
Plain-English summary
Exactech, Inc. is recalling the Equinoxe Ergo Modular Impactor Handle, model 321-09-05. About 120 units were distributed across 25 US states and Puerto Rico, and to Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, the United Kingdom, the United Arab Emirates and Slovenia. The FDA has classified this recall as Class II.
The impactor handle may be missing a cross-pin.
All lots are affected. The device carries UDI-DI 10885862557674.
Facilities can identify affected handles by the part number and UDI above, and may contact Exactech, Inc. for further information.
The recalled product
- Product
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
- Manufacturer
- Exactech, Inc.
- Affected units
- 120
Distribution
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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