Zimmer Biomet Spine, Inc recalls Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

Recall date

June 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2397-2016

FDA classification

Class II

Brand / firm

Zimmer Biomet Spine, Inc

Sold / distributed

Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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