FDA-Device2016-08-17Class II
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Zimmer Biomet Spine, Inc
Hazard
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.
Sold states
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Affected count
5
Manufactured in
310 Interlocken Pkwy, Suite 120, Broomfield, CO, United States
Products
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2397-2016Don't want to check this manually?
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