FDA Medical Device Recalls (openFDA)
Zimmer Biomet Spine, Inc: Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
- Recall number
- Z-2398-2016
- Recalling firm
- Zimmer Biomet Spine, Inc
- Product
- Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
- Status
- Terminated
- Initiated
- 2016-06-30
- Posted
- not on file
- Terminated
- 2017-03-15
- Reason
- 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.
- 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
- 5
- Distribution
- Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
- Lot, serial or model codes
- Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
- 510(k) numbers
- ["K153695"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3012447612
- Firm city
- Broomfield
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28