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.
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 classified as FDA Class II, and the hazard involves potential contamination from packaging residue without reported 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 GSF PCT knee implants. The affected devices are indicated for patients with painful or disabling knee joints due to osteoarthritis or traumatic arthritis, previous tibial condyle or plateau fractures, varus or valgus deformities, or revision of previous arthroplasty procedures. The devices are designed for cemented use only.
The recall is due to a packaging issue where the LDPE bag may adhere to the highly polished surface of the implants. 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 in the United States and 23 other countries. Patients who have had these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿
- Manufacturer
- Zimmer Biomet, Inc.
- 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 →Related recalls
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