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Zimmer Biomet Spine, Inc recalls Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Recalled August 17, 2016 · FDA recall Z-2398-2016 · Zimmer Biomet Spine
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. · FDA Class II
Units
5
Sold at
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Description
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.
Product
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Manufacturer(s)
Zimmer Biomet Spine, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →