Pega Medical recalls SLIM handle instruments with mismatched lot numbers to prevent surgical errors. Affected items have lot code B204-1 on handle but B204-01 on packaging.
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Pega Medical is recalling orthopedic surgical instrument handles for the SLIM system because the lot number on the handle doesn't match the packaging label. This mismatch could lead to surgical errors if the wrong instrument is used during procedures.
The lot number on the handle (B204-1) doesn't match the lot number on the packaging (B204-01). This mismatch could lead to using the wrong instrument during surgery, potentially causing surgical errors.
Orthopedic surgeons and surgical teams using the SLIM system are most at risk. Patients undergoing procedures with these instruments could be affected if the mismatch causes incorrect instrument use.
Check if the handle has an etched lot code #B204-1 and the packaging label shows Lot# B204-01. The product is sold as the SLIM handle with catalog number SLM-HND100.
Verify the handle has lot code B204-1 and packaging shows Lot# B204-01.
The lot number on the handle does not match the lot number on the packaging label, which could lead to surgical errors.
Check if the handle has lot code B204-1 and packaging shows Lot# B204-01. If it matches, it is not affected.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Pega Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2038-2020 — Pega Medical Pega Medical Hello, I own a Pega Medical that is covered by recall Z-2038-2020 from Pega Medical. 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.
