Smith & Nephew Recalls D-RAD Locking Pegs Due to Incorrect Expiration Dates
Smith & Nephew is recalling 19 units of D-RAD locking pegs because the expiration dates on the labels are incorrect and later than the actual dates.
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 and involves a labeling error regarding expiration dates, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Smith & Nephew, Inc. is recalling 19 units of D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic. The recall is due to incorrect expiration dates on the product labeling, where the actual expiration dates are earlier than the dates printed on the label.
The affected product is identified by Batch number 15KM05493. The distribution pattern includes the United States (Nationwide) and internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore.
Consumers and healthcare providers should stop using the affected product and contact Smith & Nephew, Inc. for further instructions.
The recalled product
- Product
- D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Orthopedic
- Hazard
- Affected units
- 19
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 (1)
- Batch number 15KM05493
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Smith & Nephew, 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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