JOURNEY II Knee Prosthesis Components Incorrectly Labeled and Packaged
Smith & Nephew recalled 28 JOURNEY II knee prosthesis inserts because two different articular types were mislabeled and swapped during packaging. The incorrect labeling prevents identification of the actual insert type.
What this means for you
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: FDA Class II medical device (surgical implant) with labeling and packaging errors causing product identity confusion. No reported injuries or illnesses. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Smith & Nephew, Inc. recalled 28 units of JOURNEY II BCS articular inserts (Size 5-6, Left side, 10mm height). These components are used in knee replacement prostheses. The affected batch carries Batch Number 22BM18348 and UDI/DI 00885556178010.
During labeling and packaging, two different types of JOURNEY II inserts were swapped. XLPE (cross-linked polyethylene) articular inserts were laser etched and labeled as CNSTRD (constrained) inserts. Simultaneously, CNSTRD inserts were laser etched and labeled as XLPE inserts. The incorrect labeling prevents accurate identification of the actual insert type.
The recalled units were distributed worldwide, including throughout the United States and Japan. Healthcare facilities that received products from this batch should verify the actual insert type prior to use.
The recalled product
- Product
- JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- mis-labeling
- packaging-error
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 (2)
- UDI/DI 00885556178010
- Batch Number 22BM18348
Distribution
Distributed nationwide across the United States.
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