Zyston¿ Transform Implant Kit recall
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Why was Zyston¿ Transform Implant Kit recalled?
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
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?
Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
- Product
- Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
- Recalling firm
- Zimmer Biomet Spine, Inc
- Quantity
- 5
- Distribution
- Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
- Recall date
- August 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)