AcuMatch Hip System Recalled for Loss of Vacuum Integrity
Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.
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: FDA Class II device recall. The vacuum loss represents a risk-of-harm condition with no documented injuries or illnesses. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling the AcuMatch Hip System, Catalog Number 142-32-27, due to loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints related to vacuum loss affecting 4 devices. Loss of vacuum in the device packaging could compromise product integrity.
The recalled devices have been distributed in the United States and internationally. In the United States, distribution includes: NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, and AR. Internationally, devices were distributed to Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom. Affected serial numbers include A673200, A673204, and A673209.
Patients implanted with this device or healthcare providers with affected inventory should contact Exactech, Inc. immediately for further information and instructions regarding this recall.
The recalled product
- Product
- AcuMatch Hip System, Catalog Number 142-32-27
- Manufacturer
- Exactech, Inc.
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 (4)
- GTIN 10885862538192
- Serial Numbers: A673200
- A673204
- A673209
Distribution
Part of a larger recall action
This product is one of 12 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.
See all 12 products in this recall →Related recalls
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