The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1260-2024·Announced 2024-03-13

X3 Triathlon Orthopedic Insert Recalled Due to Potential Packaging Breaches

Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.

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 of a sterile medical implant with potential packaging breaches that could compromise sterility and create a risk of infection or other patient harm. The risk-of-harm nature of potential contamination of an implantable device justifies a High severity score.

Plain-English summary

Howmedica Osteonics Corp. has recalled 143 units of the X3 Triathlon CS Insert No. 6 10 mm orthopedic implant. The recall was initiated because of potential packaging breaches affecting both the inner blister and outer sterile blister in which the device is sealed.

Breaches in sterile packaging can allow contaminants to reach the implant, potentially compromising its sterility prior to use. The affected lot numbers are 1L0WAY, 323EAY, A72D9D, 9885E1, 9Y397R, and L573YP, with an expiration date of October 7, 2028.

The device was distributed nationally throughout the United States and internationally to Australia, Canada, Chile, Colombia, Korea, and Japan. Patients who received an implant from the recalled lots should consult their healthcare provider.

The recalled product

Product
X3 TRIATHLON CS INSERT NO 6 10 MM
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
143

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 (9)

  • Part No. 5531-G-610-E
  • GTIN: 07613327390575
  • Lot No. 1L0WAY
  • 323EAY
  • A72D9D
  • 9885E1
  • 9Y397R
  • L573YP
  • Expiration Date: 10/07/2028.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Howmedica Osteonics Corp. 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 8 products in this recall →

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