Total Joint Orthopedics recalls Klassic BiPolar Head implants with potential packaging defects that could compromise sterility, risking infection after surgery. Affected models include 3205.41.022 to 3205.60.028.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Total Joint Orthopedics is recalling Klassic BiPolar Head implants due to a potential packaging defect that might compromise the sterile barrier. If the device is implanted, this could lead to infection. The recall affects specific model numbers and lot numbers.
The packaging may not maintain sterility properly, which could lead to contamination of the implant. If the device is implanted, this contamination might cause infection after surgery. The defect is not present in all packaging but only in specific batches.
Patients who have received the recalled Klassic BiPolar Head implants during surgery are most at risk. The recall applies to specific model numbers and lot numbers sold between 2020 and 2023.
Check the model/catalg number on the packaging or implant label. Affected items include Klassic BiPolar Heads with model numbers 3205.41.022 through 3205.60.028 and lot numbers starting with 00814703011931.
Look for model numbers 3205.41.022 to 3205.60.028 and lot numbers starting with 00814703011931 on the packaging or implant label.
The recall is for potential packaging defects that could compromise sterility, but the risk of infection is low if the device is properly handled and implanted.
Check the model number on the packaging or implant label. Affected items include Klassic BiPolar Heads with model numbers 3205.41.022 through 3205.60.028 and lot numbers starting with 00814703011931.
The recall does not require immediate action for patients who have already received the implant. Contact your surgeon for guidance on next steps.
We’ve drafted a message you can send Klassic BiPolar to request your refund or repair — edit it as you like.
Subject: Recall Z-0432-2026 — Klassic BiPolar Klassic BiPolar Hello, I own a Klassic BiPolar that is covered by recall Z-0432-2026 from Klassic BiPolar. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
