The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0027-2022·Announced 2021-10-13

ARTHROFOCUS Polyethylene Tibial Inserts recalled for packaging defect

Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device 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: This is an FDA Class II recall with no reported illnesses or injuries to date. The defect—missing oxygen barrier in packaging—creates a risk-of-harm scenario where polyethylene material degradation could occur, potentially affecting long-term implant performance. Under the severity rubric, this qualifies as a risk-of-harm product without reported injury, justifying a High (3) classification.

Plain-English summary

Exactech, Inc. is recalling ARTHROFOCUS Polyethylene Tibial Inserts (Product Lines 256-12-XX and 256-13-XX). These orthopedic implants are used in knee replacement procedures. Twelve devices are affected by this recall.

The devices were packaged in vacuum bags that lacked an additional oxygen barrier layer. This packaging defect could allow oxygen exposure to the polyethylene material during storage and distribution, potentially compromising the structural integrity and long-term performance of the orthopedic implant.

The affected devices have been distributed worldwide, including throughout the United States and internationally to countries including Canada, Japan, Australia, and numerous others.

Patients who have received these implants should consult with their healthcare provider. Exactech has provided detailed lists of affected serial numbers and product identifiers. Healthcare providers should verify their inventory against these affected devices and take appropriate action based on FDA guidance.

The recalled product

Product
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Manufacturer
Exactech, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

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 (18)

  • Item Number (Device Identifier
  • Serial number(s)): 256-12-02 (No Device Identifier
  • 1208624
  • 1208625
  • 1208626
  • 1208627)
  • 256-12-03 (10885862066633
  • 1208774
  • 1446326)
  • 256-13-02 (No Device Identifier
  • 1208710
  • 1208715)
  • 256-13-03 (No Device Identifier
  • 1208859
  • 1208863)
  • 256-13-04 (No Device Identifier
  • 1209010
  • 1209013)

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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