The Recall Desk
HighFDA (Devices)·Z-2107-2023·Announced 2023-07-19

Orthopedic Screw Recall Due to Undersized Head in Surgical Device

Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.

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 recall of a risk-of-harm surgical device with significant failure potential (screw head passing through bone plate could compromise osteotomy fixation). No illnesses or injuries reported. Per rubric, recalls with theoretical hazards and no reported harm score at most 3; this qualifies as a risk-of-harm product and reaches that threshold.

Plain-English summary

Osteomed, LLC is recalling REF: 218-1604 Profile Zero Auto-Drive Screws (1.6mm x 4mm) because certain lot numbers contain an undersized screwhead. This undersized head has the potential to pass through the bone plate hole during surgical fixation of osteotomies, which could compromise the integrity of the surgical repair.

The affected screws are sterile, prescription-only surgical devices. Recall includes lot numbers 1177027, 1177718, and 1177812. Distribution was nationwide in Arizona, California, Florida, Georgia, Kansas, Kentucky, Maryland, Missouri, Montana, Nebraska, New York, Tennessee, Texas, and Singapore.

Healthcare providers and hospitals that received these affected lot numbers should immediately remove them from inventory and quarantine remaining stock. Surgeons should verify the lot number of any Profile Zero Auto-Drive Screws before use in osteotomy procedures. Contact Osteomed, LLC for return and replacement information.

The recalled product

Product
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Manufacturer
Osteomed, LLC
Category
Medical Device — Orthopedic / Surgical Implant
Hazard

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 # 1177027
  • 1177718
  • 1177812 / UDI-DI: (01)00845694034258

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Osteomed, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Osteomed, LLC

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Same hazard · component defect

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