The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2296-2014·Announced 2014-08-27

Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints about breakage. The recall covers corrective actions taken earlier this year.

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 involves a structural defect (breakage) in a medical device. While no specific injuries or deaths are reported in the source text, the risk of harm from a broken implant component during or after surgery warrants a High severity rating under the rubric for risk-of-harm products.

Plain-English summary

Zimmer, Inc. has initiated a retrospective recall of the Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top (TASP) components. The recall was triggered by complaints reporting breakage of these trial articular surface provisionals. This action covers corrective measures that Zimmer implemented earlier in the year regarding these specific devices.

The affected products are nonsterile trial components used in knee surgery. The recall includes specific item numbers and lot numbers, with distribution events recorded worldwide, including the United States, Australia, Canada, Germany, India, Japan, Korea, and Singapore. The FDA has classified this as a Class II recall.

Healthcare providers and patients who have used these specific trial components should contact Zimmer, Inc. for further information regarding the corrective actions and any necessary follow-up. Consumers should not attempt to use these trial components if they have concerns about their integrity.

The recalled product

Product
Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP…
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
70,986

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Zimmer, Inc. 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 6 products in this recall →

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