Recall Z-2397-2016— Zimmer Biomet Spine, Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet Spine, Inc, initiated 2016-06-30, terminated 2017-03-15. It names one FDA 510(k) clearance: K153695. Product: Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.. 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..
- Recalling firm
- Zimmer Biomet Spine, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-30
- Terminated
- 2017-03-15
- Firm location
- Broomfield, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.