Z-2397-2016Class II

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

Name: Z-2397-2016 Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile
Creator: Zimmer Biomet Spine, Inc
Published: 2016-06-30
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2016-06-30 / Terminated

FDA source

Zimmer Biomet Spine, Inc began a recall of Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile on 2016-06-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2397-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Posted: 2016-08-11
Terminated: 2017-03-15
Recalling firm: Highridge Medical, LLC
Product: Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
FDA root cause: Under Investigation by firm
Action: Verbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email notifications will also be sent to each recall notification addressee before distributing the recall documentation via Federal Express.
Quantity in commerce: 5
Distribution: Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Product codes and lots: Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2397-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2397-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11
Z-2398-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code MAX

K153695Class IIBiomet Spine Fusion SystemBiomet Spine, LLC / cleared 2016-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)