Brasseler USA recalls 103 tubes of Steinmann pins labeled incorrectly as KM169-39-76 instead of KM168-39-76. This labeling error may cause confusion in medical use. Affected units were sold with lot number NR8ZR.
103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.
Brasseler USA is recalling 103 tubes of Steinmann pins that were incorrectly labeled as KM169-39-76 instead of KM168-39-76. This labeling error could lead to using the wrong pin type during medical procedures, which might cause complications.
The pins were labeled with the wrong product code (KM169-39-76 instead of KM168-39-76). This labeling error could lead to using the wrong pin type during surgery, potentially causing improper bone fixation and complications.
Orthopedic surgeons and medical professionals who use these pins for bone fracture repairs may be affected. Patients receiving the incorrect pins could face complications from improper surgical fixation.
Check for tubes labeled as KM169-39-76 Single Diamond Smooth Steinmann Pins with lot number NR8ZR. The product is used for internal fixation of large bone fractures.
Verify the product label on the tube to ensure it matches the correct product code KM168-39-76.
The correct product code is KM168-39-76 Single Diamond Smooth Steinmann Pins.
Look for tubes labeled as KM169-39-76 with lot number NR8ZR.
The recall record does not specify a remedy.
We’ve drafted a message you can send Brasseler USA to request your refund or repair — edit it as you like.
Subject: Recall Z-0884-2020 — Brasseler USA Brasseler USA Hello, I own a Brasseler USA that is covered by recall Z-0884-2020 from Brasseler USA. 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.
