10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. recall
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2…
Why was 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. 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: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.
- Product
- 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2…
- 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)