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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to…"
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…
- 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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