The Recall Desk
HighFDA (Devices)·Z-0921-2013·Announced 2013-03-20

Genesys Orthopedic Recalls 3.75mm Fixed Cervical Screws Due to Manufacturing Residue

Genesys Orthopedic Systems is recalling 3.75mm x 12mm Fixed Cervical Screws because manufacturing residue may be present. The residue poses risks of infection, delayed fusion, or revision surgery.

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 involves a medical device where the hazard (infection, non-fusion) is a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria.

Plain-English summary

Genesys Orthopedic Systems, LLC is recalling 3.75mm x 12mm Fixed Cervical Screws, which are components of the Genesys Spine Anterior Cervical Plate System. The recall involves 9 cervical screws identified by Part Number GCSF37512 and Lot Number 0243. These devices are intended for anterior screw fixation to the cervical spine.

The recall was initiated because manufacturing residue may be present on the cervical screws. The use of these products may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.

The affected products were distributed nationwide in the USA, including the states of California and Texas. Healthcare providers and patients should contact Genesys Orthopedic Systems for further instructions regarding the removal or replacement of these devices.

The recalled product

Product
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Manufacturer
Genesys Orthopedic Systems, LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
9

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)

  • Part Number: GCSF37512 and Lot Number: 0243

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

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