Synthes OPAL Spinal Fusion Cage Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 6 units of OPAL Spacers because the outer packaging label does not match the product inside or its intended use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error where the packaging does not match the product inside, which fits the criteria for a moderate severity recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 6 units of the Oblique Posterior Atraumatic Lumbar (OPAL) System, specifically the Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve. The recall is due to a labeling error where the label on the outer packaging does not match the product inside or the intended use of the device.
The affected units are identified by Lot # 9984134 and Catalog ID 08.803.051. The product is indicated for use in patients with degenerative disc disease at one or two contiguous levels from L2 to S1. The OPAL Spacer is intended to be used with Synthes supplemental fixation and should be packed with autogenous bone graft.
The affected units were distributed in the United States to Ohio and North Dakota. Healthcare providers and patients should check their inventory for this specific lot and catalog number. If the product is found, it should be removed from use and returned to Synthes (USA) Products LLC according to their instructions.
The recalled product
- Product
- Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 6
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 (4)
- Lot # 9984134
- Catalog ID 08.803.051
- OPAL Spacer 10 mm x 24 mm
- 11 mm Height - Revolve
Distribution
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