[pending] Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers:
Pending LLM rewrite. Source: FDA_DEVICE Z-0580-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
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 — Devices
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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