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FDAJune 30, 2016device

Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biomet spinezimmerzimmer biomet

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. — Recall Details · AllClear