Reported Aug 17, 2016 · Terminated
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Zimmer Biomet Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet Spine, Inc · 310 Interlocken Pkwy · Broomfield, CO · 80021-3479
Is this the product you have?
- Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
- Lot codes and dates
- Lot Numbers
2016244391201624439420162443952016244396201624439720162444242016244426201624442720162444282016244430
- Lot Numbers
- Amount recalled
- 5
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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