10-1398M - SpF-PLUS Implantable Stimulator. Indicated recall
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Why was 10-1398M - SpF-PLUS Implantable Stimulator. Indicated recalled?
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
- Product
- 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
- Recalling firm
- EBI Patient Care, Inc.
- Quantity
- 33 units total
- Distribution
- Nationwide distribution only.
- Recall date
- May 31, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)