Zimmer Persona Tibial Articular Surface Inserter Recalled for Deformation Risk
Zimmer, Inc. is recalling 618 units of the Persona Tibial Articular Surface Inserter because they did not undergo heat treatment, creating a risk of tip deformation.
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 hazard involves a risk-of-harm product (instrument deformation) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 618 units of the Persona Tibial Articular Surface Inserter. This sterilizable instrument is intended for use in multiple total knee arthroplasty procedures to seat the articular surface implant onto the tibial baseplate.
The recall was initiated because the affected products did not undergo the required heat treatment hardening step. This manufacturing omission leads to the potential for deformation of the instrument's tip.
The affected units were distributed worldwide, including nationwide in the United States and in Korea, Singapore, Canada, and Japan. The specific part number is 42-5299-001-00, and the affected lot numbers are 56572679, 56573170, 56572918, 56573378, 56572975, 56573379, 56572978, 56574223, 56572981, 56574291, 56572982, 56574292, 56573071, 56574316, 56573115, 56574317, 56573116, 56574318, and 56573154. Healthcare providers should stop using these instruments and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 618
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 (19)
- Part Number 42-5299-001-00 Lots: 56572679
- 56573170
- 56572918
- 56573378
- 56572975
- 56573379
- 56572978
- 56574223
- 56572981
- 56574291
- 56572982
- 56574292
- 56573071
- 56574316
- 56573115
- 56574317
- 56573116
- 56574318
- 56573154.
Distribution
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