Pega Medical recalls SLIM Handle (catalogue # SLM-HND10:100) due to risk of jamming with the Driver component, potentially causing injury during orthopedic procedures.
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
Pega Medical is recalling the SLIM Handle component (catalogue # SLM-HND100) because it can jam with the Driver due to a detached internal Connector Ring. This hazard could cause injury during orthopedic surgeries if the handle malfunctions.
The handle can jam with the Driver component because an internal Connector Ring may detach. This jamming could cause the handle to become stuck, potentially leading to injury during surgical procedures.
Orthopedic surgeons and medical staff who use the SLIM Handle during procedures are most at risk. Patients undergoing surgery with this component may also be affected.
Check for the SLIM Handle with catalogue number SLM-HND100. The product was sold in specific lots: 150115-09, 160427-01, and A162-02.
Inspect the handle for any signs of a detached internal Connector Ring.
The recall affects the medical device used during surgery, but patients are not directly affected unless the device malfunctions during their procedure.
Check the catalogue number and lot numbers listed in the recall notice to determine if your handle is affected.
Look for the catalogue number SLM-HND100 and lot numbers 150115-09, 160427-01, or A162-02 on the handle.
We’ve drafted a message you can send Pega Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2278-2019 — Pega Medical Pega Medical Hello, I own a Pega Medical that is covered by recall Z-2278-2019 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.
