Agency classClass IIOur severity:High FDA (Devices)·Z-0021-2022·Announced 2021-10-13

OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier

Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.

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 a Class II FDA recall involving a risk-of-harm medical device (orthopedic implant) where the packaging defect could compromise sterility. Although no illnesses or injuries have been reported, the potential for serious patient harm from non-sterile implants justifies a High severity rating.

Plain-English summary

Exactech, Inc. recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts, which are used in knee replacement procedures. The recall encompasses seven product line variants (PS, PSC, CR, CR Slope+, CR Slope++, CRC, and CC) and affects devices distributed worldwide, including throughout the United States and to over 40 additional countries.

The inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. This packaging deficiency creates a risk that the devices' sterility or integrity could be compromised during storage and transportation before use.

The FDA classified this as a Class II recall. Affected devices are identified by product line numbers (02-012-35-XXXX, 02-012-44-XXXX, 02-012-47-XXXX and others) and specific serial numbers. The recall was initiated in February 2022.

The recalled product

Product: OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line…
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic implant / Knee replacement
Hazard: packaging-defect
sterility-compromise
Affected units: 109,787

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 (20)

a. Item Number (Device Identifier
Serial number(s)): 02-012-35-0009 (10885862001641
1678465
1678471
1678474
1678481
1957753
2006036
2006037
2013812
2043308
2092688
2554898
2573058
4705904)
02-012-35-0011 (10885862001658
1678302
1678309
1678312
1963089

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

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