The Recall Desk
HighFDA (Devices)·Z-1819-2015·Announced 2015-07-01

Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk

Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.

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: The recall is classified as FDA Class II and involves a risk-of-harm product where the device may malfunction during a surgical procedure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Orthofix, Inc. is recalling 36 units of the Centurion POCT System Drill Guide, part numbers 69-1010 and 69-1012. These devices are used to interface with various drill tips during the drilling procedure of bone preparation. The recall covers all lot codes and includes nationwide distribution to California, Virginia, Florida, Idaho, Colorado, Oregon, Pennsylvania, Oklahoma, South Carolina, and Texas.

The recall is being conducted because there is a possibility that the thumb button remains in the depressed (unlocked) position. This condition allows the threaded sleeve, also known as the drill stop, to unintentionally rotate and change the depth setting. The agency has classified this as a Class II recall.

Healthcare providers and facilities that have received these devices should stop using them and contact Orthofix, Inc. for instructions on how to return or replace the affected units.

The recalled product

Product
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Manufacturer
Orthofix, Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
36

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)

  • All lot codes

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Related recalls

Same manufacturer · Orthofix, Inc

See all →

Same hazard · malfunction

See all →