Device recall: Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Class II FDA enforcement event 74687. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zimmer Biomet Spine, Inc started this device recall on 30 Jun 2016. The firm address in the FDA record is in Broomfield, CO. FDA put the recall in Class II. FDA event 74687 has 2 product records. The first FDA enforcement report date is 17 Aug 2016. The record gives the status Terminated, with the termination date 15 Mar 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Recalling firm
Zimmer Biomet Spine, Inc, Broomfield, CO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2397-2016 | Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. | 5 | Class II | Terminated | 17 Aug 2016 |
| Z-2398-2016 | Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. | 5 | Class II | Terminated | 17 Aug 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Oct 2023 | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System | Device | Class II | 1 |
| 30 Jul 2018 | Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indica | Device | Class II | 3 |
| 10 May 2017 | Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle – 90 in-lbs Model Number | Device | Class II | 1 |
| 16 Mar 2017 | Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Syst | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2397-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 74687. https://recallregister.com/fda/ii/74687/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
- What quantity of product is in FDA event 74687?
- The event has 2 product records. The first record gives this quantity:
5
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.