K2M recalls YUKON Polyaxial Screws (3.5 X 12 mm to 5.0 X 30 mm) due to a manufacturing error that may prevent screws from mating with inserters. This affects medical devices sold in the U.S. since 2018.
Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.
K2M is recalling YUKON Polyaxial Screws that have a manufacturing error preventing them from properly mating with screw inserters. This could lead to improper use in medical procedures if the screws don't function as intended.
The screws have a manufacturing defect that prevents them from correctly engaging with the screw inserter or set screw. This could lead to improper fixation during surgery, potentially causing complications if the screws fail to hold properly.
Medical professionals and patients using these screws for surgical procedures. The risk is low as the issue is a manufacturing error that doesn't cause immediate harm but may affect surgical outcomes.
Check for YUKON Polyaxial Screws with sizes 3.5 X 12 mm to 5.0 X 30 mm. The catalog numbers include 7601-03512 through 7601-05030. These were sold in the U.S. starting in 2018 with lots labeled FUVD through FUXV.
Identify if your screws match the listed sizes and catalog numbers (e.g., 3.5 X 12 mm, 7601-03512).
K2M recalls these screws due to a manufacturing error that prevents them from mating with the screw inserter or set screw as intended.
The recall does not include a remedy, so no action is required beyond checking if your screws match the listed specifications.
The screws may not function properly, which could lead to surgical complications, but the recall is for a manufacturing error, not an immediate safety hazard.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-0110-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-0110-2020 from K2M. 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.
