The Recall Desk
HighFDA (Devices)·Z-2108-2023·Announced 2023-07-19

Osteomed AutoDrive Screws Recalled for Undersized Screw Head

Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a structural defect in a surgical implant that could compromise fixation. No illnesses or injuries have been reported to date, placing this at the threshold for High severity per the risk-of-harm product category.

Plain-English summary

Osteomed, LLC is recalling REF 218-1604-SP-10 Profile 0 4mm AutoDrive Screws (Sterile, Qty 10). These are surgical screws used in orthopedic osteotomy procedures.

The recalled screws have undersized screw heads that have the potential to pass through the plate hole. This could affect the surgical fixation.

The recall affects product lots 1177274, 1177331, and 1177823. Distribution was nationwide in the following US states: Arizona, California, Florida, Georgia, Kansas, Kentucky, Maryland, Missouri, Montana, Nebraska, New York, Tennessee, and Texas, as well as Singapore.

The recalled product

Product
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Manufacturer
Osteomed, LLC
Category
Medical Device — Orthopedic Hardware / Surgical Fixation
Hazard
  • implant-defect
  • fixation-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # 1177274
  • 1177331
  • 1177823 / UDI-DI: (01)00845694066006

Distribution

Distributed nationwide across the United States.

Related recalls

Same category