The Recall Desk
HighFDA (Devices)·Z-1133-2023·Announced 2023-02-22

iTotal Identity Impactor Handle surgical screws may loosen during procedures

Conformis Inc. is recalling the iTotal Identity Impactor Handle due to potential loose screws that could fall into patients during surgical procedures. Approximately 70 units from lot D221301 were distributed across multiple U.S. states.

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: This is an FDA Class II recall with no reported injuries or hospitalizations. The hazard is theoretical—the absence of epoxy thread locker could cause a screw to loosen and fall into a patient during surgery—but no incidents have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Conformis, Inc. is recalling the iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE, a surgical instrument.

The recall was initiated because Loctite thread locker (epoxy) may not have been properly applied to a screw that is part of the handle. Without this epoxy coating, the screw can loosen and potentially fall into the patient during a surgical procedure.

Approximately 70 units from lot D221301 were distributed across the United States, including Alabama, Arizona, Colorado, Florida, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, Nebraska, New Hampshire, Nevada, New York, Ohio, Tennessee, Wisconsin, and Wyoming.

Healthcare providers who have received these units should immediately discontinue use and contact Conformis, Inc. for replacement or return instructions.

The recalled product

Product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Manufacturer
Conformis, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • loose-screw
  • foreign-body

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 (1)

  • UDI-DI 00810933030582 Lot D221301

Distribution

Distributed nationwide across the United States.

Related recalls

Same category