Wright Medical Recalls Knee Components Due to Shelf Life Labeling Errors
Wright Medical Technology Inc is recalling 729 knee components due to potential inaccuracies in labeled shelf life at the Toulon, France facility.
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 hazard is limited to labeling inaccuracies regarding shelf life with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wright Medical Technology Inc is recalling 729 units of knee components, including femoral components, tibial inserts, tibial plateaus, intramedullary stems, and patellar components. The recall is due to potential inaccuracies in the labeled shelf life on all products packaged at the Toulon, France facility.
The affected products were distributed nationwide in the United States and internationally to numerous countries, including Canada, various European nations, and locations in Asia, South America, and the Middle East. The source text does not specify the exact number of patients affected or report any illnesses or injuries associated with these products.
Consumers and healthcare providers should check their inventory for the specific part numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to Wright Medical Technology Inc or the appropriate distributor for replacement or refund.
The recalled product
- Product
- Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952…
- Manufacturer
- Wright Medical Technology Inc
- Hazard
- Affected units
- 729
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 (20)
- ROTULE "913" D=32
- Part Number PGA00030
- Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-
- PGA00050
- Lot Numbers: V11272719
- W02300988
- W09372781
- and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-
- PGA00054
- Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-
- PGA00080
- Lot Numbers: X02396582
- X05401377
- and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-
- PGA00110
- Lot Numbers: W09359102
- X03396584
- and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-
- PGA00174
- Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Wright Medical Technology 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.
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