Zimmer Biomet Recalls Zyston Transform Implant Kits Due to Locking Defect
Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the 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 the source describes a functional defect in a medical implant without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet Spine, Inc. has announced a voluntary field action for the Zyston Transform Implant Kit, Model Number PCR8200-3101. The recall involves five units of the device, which is labeled as sterile.
The recall is being issued because the locking mechanism on the implant is not functioning as intended. The affected units were distributed nationwide to Pennsylvania, Texas, Tennessee, Nevada, Virginia, West Virginia, and Kentucky. No units were distributed to Canada, other foreign countries, or to VA, government, or military consignees.
The specific lot numbers affected by this recall are 2016244391, 2016244394, 2016244395, 2016244396, 2016244397, 2016244424, 2016244426, 2016244427, 2016244428, and 2016244430. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with the field action.
The recalled product
- Product
- Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
- Manufacturer
- Zimmer Biomet Spine, Inc
- Category
- Medical Device — Spine Implant
- 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: 2016244391
- 2016244394
- 2016244395
- 2016244396
- 2016244397
- 2016244424
- 2016244426
- 2016244427
- 2016244428
- 2016244430.
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.
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