The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1049-2018·Announced 2018-03-21

Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 13,227 units of CR-FLEX PCT FEM knee implants. The recall affects specific model numbers including C-R, D-L, D-R, E-L, E-R, F-L, F-R, G-L, and G-R MINUS variants. These devices are indicated for patients with severe knee pain and disability.

The recall was initiated because the LDPE bag packaging for these highly polished implants may adhere to the surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging.

The affected units were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Canada, China, India, Japan, and Mexico. Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices.

The recalled product

Product
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-L MINUS CR-FLEX PCT FEM G-R MINUS This device is indicated for…
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
13,227

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 48 recalled by Zimmer Biomet, 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 48 products in this recall →

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