Synthes Titanium Spinal Locking Caps Recalled for Post-Operative Loosening
Synthes USA is recalling 745 Titanium Minimally Invasive Reduction Screw System Locking Caps due to a risk of post-operative loosening if the construct is mis-aligned during final tightening.
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 with a risk of post-operative loosening, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synthes USA HQ, Inc. is recalling 745 units of the Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502. These are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
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 the 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. All lots are affected. Healthcare providers and patients should contact Synthes for further instructions regarding the recall.
The recalled product
- Product
- Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 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
- 745
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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