Synthes Polyaxial Screw Body Recalled for Potential Post-Operative Loosening
Synthes USA is recalling 757 units of Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bodies due to reported complaints of post-operative locking cap 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 medical device with a risk of harm (post-operative loosening) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synthes USA HQ, Inc. is recalling 757 units of the Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500. These non-cervical spinal fixation devices are intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. The recall covers all lots of the product.
The recall was initiated following a detailed investigation into reported complaints of post-operative locking cap loosening. Synthes concluded that if the construct is mis-aligned during final tightening, there is a potential for locking caps to loosen post-operatively in certain situations.
The affected products were distributed nationwide, including in California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. Healthcare providers should contact Synthes USA HQ, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
- Manufacturer
- Synthes USA HQ, Inc.
- Category
- Medical Device — Spinal Fixation
- Affected units
- 757
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 lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Synthes USA HQ, Inc. 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.
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