The Recall Desk
ModerateFDA (Devices)·Z-1360-2015·Announced 2015-04-08

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.

What this means for you

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 he
Manufacturer
Zimmer, Inc.
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