Exactech Optetrak Logic PS Knee System Vacuum Loss Recall
Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.
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: This is an FDA Class II medical device recall involving loss of protective vacuum in orthopedic implant packaging, which could affect product integrity. However, no injuries, hospitalizations, or deaths have been reported, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling the Optetrak Logic PS Knee System, Catalog Number 02-012-35-5009, due to loss of vacuum in the inner-most vacuum bag. Exactech has received 3 complaints involving 4 devices related to this vacuum loss issue.
Loss of vacuum in the protective packaging may compromise product integrity and potentially affect the safety of the implant system for patients who receive affected devices.
The affected devices were distributed throughout the United States (including New York, Texas, Indiana, Illinois, Minnesota, Kentucky, Virginia, Maryland, Tennessee, Georgia, New Hampshire, Maine, South Carolina, Nevada, Florida, and Arkansas) and internationally in Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom.
Patients and healthcare providers who have received affected devices should contact Exactech, Inc. for information and guidance regarding this recall.
The recalled product
- Product
- Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
- Manufacturer
- Exactech, Inc.
- Hazard
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 (3)
- GTIN 10885862001924
- Serial Numbers: A649282
- A649289
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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