The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1340-2016·Announced 2016-04-13

Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product information on the box differed by sides, showing conflicting part and lot numbers.

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 classified as FDA Class II due to a labeling discrepancy (conflicting part and lot numbers on the box). This fits the 'Moderate' severity criterion for minor labeling errors or low-risk contamination where the hazard is primarily administrative or identification-related rather than a direct physical defect causing injury.

Plain-English summary

Zimmer Manufacturing B.V. is recalling the Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile, reference 42-5114-005-14. The recall was initiated after the firm received a customer complaint indicating that the information shown on the product box differed by sides. One side of the box displayed Part Number 42-5114-008-18 and Lot 62632101, while the other side displayed Part Number 42-5114-005-14 and Lot 62646580.

The affected products were distributed in the United States (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and in foreign countries including Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain. The FDA has classified this recall as Class II, which means the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and consumers should check their inventory for the specific lot number 62646580 and reference 42-5114-005-14. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from whom it was purchased. No specific instructions for end-users are provided in the source text, but standard medical device recall procedures apply.

The recalled product

Product
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
Manufacturer
Zimmer Manufacturing B.V.
Category
Medical Device — Orthopedic Implant
Hazard

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 (1)

  • lot 62646580

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Manufacturing B.V. 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 →

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