The Recall Desk
SevereFDA (Devices)·Z-2155-2012·Announced 2012-08-15

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 sma
Manufacturer
Stryker Spine
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.