Expandable spinal cages recalled because they may lose height or collapse
Medtronic Sofamor Danek is recalling 275,260 Catalyft PL and PL40 expandable interbody spacers because the cage may lose height or collapse, risking migration or neurological injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an implanted cage that can collapse risks migration, subsidence and neurological injury, and no injuries are reported.
Plain-English summary
The Catalyft PL and PL40 Expandable Interbody System is being recalled across model numbers including 6068073 (Catalyft PL Short 7mm) and 6068076 (Catalyft PL Long 7mm).
The expandable interbody system cage may lose height or collapse, a loss of lordosis, which Medtronic states could result in migration, subsidence and/or neurological injury. The firm states the surgical technique and instructions for use will be updated to mitigate the risk of loss of lordosis occurring.
The recall covers 275,260 units, with instructions for use M333023W048E Rev. A and surgical technique M333023W217 Rev. 2.0. Distribution was worldwide, including nationwide in the United States and Puerto Rico, and to Australia, Austria, Belgium and Canada. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Surgeons and facilities should follow Medtronic's updated technique guide and instructions.
The recalled product
- Product
- Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Mo
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal implant
- Hazard
- implant-collapse
- loss-of-lordosis
- migration
- neurological-injury-risk
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 (20)
- IFU: M333023W048E Rev. A Surgical TechniqueM333023W217
- 0836192W
- 0837725W
- 0837727W
- 0839577W
- 0839579W
- 0839591W
- 0839593W
- 0839595W
- 0841459W
- 0842257W
- 0842767W
- 0842769W
- 0845001W
- 0845003W
- 0846533W
- 0849546W
- 0849548W
- 0849998W
- 0854451W
Distribution
Distributed nationwide across the United States.
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