MicroPort Orthoped: Recall of left knee tibial bases (size 2+) with wrong base in packaging. One confirmed incident of incorrect base mix-up during surgery. Affected units: Lot 1916559, REF ETPKN2PL.
One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
MicroPort Orthopedics is recalling left knee tibial bases (size 2+) with a specific reference number (ETPKN2PL) because one surgery incident found the wrong base (size 7) inside the packaging. This could lead to incorrect surgical implant placement if the wrong base is used.
During one confirmed surgery, the packaging for a size 2 tibial base contained a size 7 base instead. This mix-up could lead to incorrect surgical implant placement if the wrong base is used during knee replacement procedures.
Surgical patients and medical facilities that received the recalled tibial bases (lot 1916559, REF ETPKN2PL) for knee surgeries. Patients using the wrong base during surgery are at risk of incorrect implant placement.
Check for the reference number ETPKN2PL and lot number 1916559 on the packaging of left knee tibial bases (size 2+). The product has a unique identifier (UDI/DI) starting with 0 0192629 08287 8.
Look for the reference number ETPKN2PL and lot number 1916559 on the packaging of left knee tibial bases (size 2+).
One confirmed incident found that the packaging for a size 2 tibial base contained a size 7 base during surgery.
The reference number is ETPKN2PL and the lot number is 1916559.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send MicroPort Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0275-2023 — MicroPort Orthopedics MicroPort Orthopedics Hello, I own a MicroPort Orthopedics that is covered by recall Z-0275-2023 from MicroPort Orthopedics. 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.