Wright Medical Recalls Extremity Components Due to Shelf Life Labeling Errors
Wright Medical Technology Inc. is recalling 840 units of orthopaedic extremity components because the labeled shelf life may be inaccurate for products packaged in Toulon, France.
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 identifies the issue as a potential labeling inaccuracy regarding shelf life without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
Wright Medical Technology Inc. is recalling 840 units of orthopaedic extremity components, including Prothese A Expansion Complete and Tige Humerale Proximale "NGR" Long. The recall covers specific part numbers and lot numbers distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and the Americas.
The recall was initiated because there may be inaccuracies on the labeled shelf life for all products packaged at the Toulon, France facility. The source text does not specify the nature of the inaccuracy or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and patients should verify the lot numbers of their devices against the recall list. If a device is affected, it should be removed from use and returned to Wright Medical Technology Inc. according to the company's instructions.
The recalled product
- Product
- Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number…
- Manufacturer
- Wright Medical Technology Inc
- Category
- Medical Device — Orthopaedic
- Hazard
- Affected units
- 840
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)
- PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM
- Part Number PPO90000
- Lot Numbers: U11113596
- W12372884
- W12376849
- X01383482
- X06391313
- X07401148
- X07401445
- and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM
- Part Number PPO90100
- Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM
- Part Number PPO90200
- Lot Numbers: X06391315
- X07401150
- X07420387
- and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM
- Part Number PPO90300
- Lot Numbers: W12383045
- W12383485
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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