Stryker Luxor Retractor Base Recalled Due to Blade Disassembly
Stryker Spine is recalling 30 Luxor Retractor Base devices because blades may disassemble from the base, causing the retractor to collapse during 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 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 recall is classified as FDA Class II and involves a structural failure (collapse in situ) of a surgical instrument, which poses a significant risk of injury to patients during procedures.
Plain-English summary
Stryker Spine is recalling 30 units of the Luxor Retractor Base, Catalog Number 48250030, Lot Code 093309. The device is a medical instrument used to provide access to the thoracic and lumbar spine from a posterior approach via a small incision. The products were manufactured by STRYKER Spine SAS in France and distributed in the USA by Stryker Spine in Allendale, NJ.
The recall was initiated after Stryker received three reports of the retractor blades becoming disassembled from the base. This failure caused the retractor to collapse in situ during use. The agency has classified this as a Class II recall.
The affected devices were distributed worldwide, including in the US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan. Healthcare providers should stop using the affected devices and contact Stryker Spine for instructions on return or replacement.
The recalled product
- Product
- LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a…
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 30
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)
- Lot Code: 093309
Distribution
Distribution scope not specified by the agency.
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