Zimmer Biomet Recalls Zyston Transform Instrument Cases Due to Locking Defect
Zimmer Biomet Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect in a medical device's locking mechanism, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet Spine, Inc. has announced a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit. The recall is being conducted because the locking mechanism on the implant is not functioning as intended.
The affected products are the Zyston Transform Instrument Case, Model Number PCR8200-2101, which are labeled as sterile. The recall covers five units distributed nationwide to Pennsylvania, Texas, Tennessee, Nevada, Virginia, West Virginia, and Kentucky. The source text does not indicate any Canadian, foreign, or government/military consignees.
The specific lot numbers associated with this recall are 2016234237, 2016234240, 2016234242, 2016234243, 2016234245, 2016234246, 2016234247, 2016234248, 2016234249, and 2016234351. Healthcare providers and facilities should verify their inventory against these lot numbers and contact the recalling firm for further instructions.
The recalled product
- Product
- Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
- Manufacturer
- Zimmer Biomet Spine, Inc
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot Numbers: 2016234237
- 2016234240
- 2016234242
- 2016234243
- 2016234245
- 2016234246
- 2016234247
- 2016234248
- 2016234249
- 2016234351.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet Spine, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet Spine, Inc
See all →- HighSpinal fixation screws recalled due to incorrect size laser marking
FDA (Devices) · 2024-01-10
- HighZimmer Biomet Recalls Vitality Spinal Fixation Set Screws
FDA (Devices) · 2019-03-06
- HighZimmer Biomet Recalls Vitality Spinal Fixation Set Screws
FDA (Devices) · 2019-03-06
- HighZimmer Biomet Recalls Vitality Spinal Fixation Set Screws
FDA (Devices) · 2019-03-06
- HighZimmer Biomet Recalls Vitality Spinal Fixation System Drivers
FDA (Devices) · 2017-06-14
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighZimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation
FDA (Devices) · 2019-07-24
- ModerateZimmer Biomet Recalls Sterile Implants Due to Packaging Design Failures
FDA (Devices) · 2017-06-21
- SevereZimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
FDA (Devices) · 2020-06-10
- HighBiomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
FDA (Devices) · 2016-06-01
- SevereZimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Failure
FDA (Devices) · 2020-06-10
- ModerateZimmer Trabecular Metal Hip Implant Shell Recalled for Missing Locking Ring
FDA (Devices) · 2014-04-30