FDA Recalls Tibial Inserts Due to Potential Sterile Packaging Breach
Howmedica Osteonics is recalling tibial inserts due to potential breaches in sterile packaging. The breach could allow device contamination and increase post-operative infection risk.
What this means for you
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 FDA Class II recall affects a sterile surgical implant where packaging breach creates contamination and infection risk. No illnesses or injuries have been reported, and the hazard is preventive/theoretical, meeting the rubric criterion for High (Score 3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling its NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM tibial inserts due to potential breaches in the inner blister and outer sterile blister packaging. The affected products were distributed nationwide in the United States and internationally to Australia, Canada, Chile, Colombia, Korea, and Japan.
The packaging breach could compromise the sterility of the device, potentially exposing the tibial insert to contamination. Tibial inserts are used in surgical procedures, and maintaining sterile packaging is essential to prevent infection. A compromised sterile barrier increases the risk of contamination and post-operative infection.
Patients who have received this device should contact their healthcare provider or surgeon if they have concerns. Healthcare facilities with inventory of the affected lot numbers (H21A0K or XY776E) should quarantine and return the product to the manufacturer per recall instructions.
The recalled product
- Product
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- packaging-breach
- contamination
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 (5)
- Part No. 5537-G-416-E
- GTIN: 07613327287745
- Lot No. H21A0K
- XY776E
- Expiration Date: 10/07/2028.
Distribution
Distributed nationwide across the United States.
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