Zimmer Biomet Spine, Inc: Medical Device Recall in 2016 - (Recall #: Z-2397-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 30, 2016

Date Posted: August 17, 2016

Recall Number: Z-2397-2016

Event ID: 74687

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5

Code Information:

Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated