Zimmer Recalls Persona Anterior Referencing Sizers Due to Specification Nonconformance
Zimmer, Inc. is voluntarily recalling 22 lots of Persona Anterior Referencing Sizers with Locking Boom because the devices do not conform to print specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a Class II medical device due to nonconformance to print specifications, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is voluntarily recalling 22 lots of the Persona Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. The devices are being removed from distribution because they do not conform to print specifications.
The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. According to the Persona Surgical Technique, the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
The recall affects 688 units distributed worldwide, including in the United States and internationally to Germany, India, the Dominican Republic, Singapore, Korea, Japan, Australia, and Canada. The specific lots affected are: 56573342, 56574505, 56574999, 56574229, 56574818, 56575000, 56574230, 56574819, 56575020, 56574301, 56574820, 56575021, 56574349, 56574861, 56575072, 56574374, 56574862, 56575105, 56574375, 56574863, 56574504, and 56574998.
The recalled product
- Product
- Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 688
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 (20)
- Part # 42-5099-088-10
- Lots: 56573342
- 56574505
- 56574999
- 56574229
- 56574818
- 56575000
- 56574230
- 56574819
- 56575020
- 56574301
- 56574820
- 56575021
- 56574349
- 56574861
- 56575072
- 56574374
- 56574862
- 56575105
- 56574375
Distribution
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