CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Zyston¿ Transform Implant Kit recalled by Zimmer Biomet Spine
Zimmer Biomet Spine is recalling Zyston¿ Transform Implant Kit, distributed nationwide in the US. The recall was initiated on 30 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2398-2016
- FDA event ID
- 74687
- Recalling firm
- Zimmer Biomet Spine, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2016
- FDA classified
- 11 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Jun 2016 | Recall initiated by company | |
| 11 Aug 2016 | Classified by FDA | +42 days |
| 17 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Where it was distributed
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Nationwide KentuckyNevadaPennsylvaniaTennesseeTexasVirginiaWest Virginia
Questions about this recall
Is Zyston¿ Transform Implant Kit recalled?
Yes. Zimmer Biomet Spine recalled Zyston¿ Transform Implant Kit on 30 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2398-2016.
Why was it 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.
Which lots are affected?
Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
Where was it sold?
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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