Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1341-2016·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 box displayed conflicting part and lot numbers on different sides.

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 and involves a labeling error (conflicting part and lot numbers on the box) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Zimmer Manufacturing B.V. is recalling the Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile. The recall affects units with Reference 42-5114-008-18. The firm initiated the recall after receiving a customer complaint indicating that the information printed on the product box differed by sides.

The discrepancy involved one side of the box showing Part Number 42-5114-008-18 and Lot 62632101, while the other side displayed Part Number 42-5114-005-14 and Lot 62646580. The product is intended for use in total knee arthroplasty. The affected units 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 U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the issue is identified as a labeling discrepancy on the packaging.

The recalled product

Product: Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling

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 62632101

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 →

Same manufacturer · Zimmer Manufacturing B.V.

See all →

High
Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
High
Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
High
Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
High
Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
Moderate
Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25

Same hazard · mis labeling