Orthofix Firebird Spinal Fixation System Torque Limiting Handle Recall
Orthofix is recalling 36 Firebird Spinal Fixation System Torque Limiting Handles because they may deliver less torque than required after sterilization, potentially causing spinal construct loosening.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (spinal construct loosening requiring corrective surgery) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Orthofix, Inc. is recalling 36 units of the Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512). The device is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium). The recall covers units distributed worldwide, including the US, Spain, Italy, and Australia.
The recall is due to a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In the worst case, this unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
- Manufacturer
- Orthofix, Inc
- Category
- Medical Device — Spinal Fixation
- 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 (20)
- BS535418105
- BS535419118
- BS535420030
- BS535419124
- BS562325021
- BS535418158
- BS535418038
- BS535418138
- BS535418012
- BS535419006
- BS535420039
- BS535418127
- BS549024010
- BS535419141
- BS535418081
- BS535418111
- BS535418117
- BS535420041
- BS535418144
- BS535420081
Distribution
Distribution scope not specified by the agency.
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