NA 412.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982210722), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K000684, K103002); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON JANUARY 30, 2026, THE PRODUCT RETURNED TO THE DISTRIBUTION CENTER CONTAINED A FOREIGN OBJECT RESEMBLING HUMAN HAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K103002. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,
• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu