Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws
Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which by definition is unlikely to cause adverse health consequences, and the source text describes a manufacturing specification issue without reporting any injuries or illnesses.
Plain-English summary
Synthes (USA) Products LLC is recalling 24 units of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws. The product is part of the Matrix Spine System and is intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
The recall was initiated because two nonconforming parts may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
The affected units, identified by Part Number 04.634.002 and Lot Number 6816781, were distributed to Michigan, Montana, and Colorado. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 24
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 04.634.002 Lot Number 6816781
Distribution
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