The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1856-2017·Announced 2017-04-26

Smith & Nephew Recalls D-RAD Orthopedic Screws Due to Incorrect Expiration Dates

Smith & Nephew is recalling 100 units of D-RAD orthopedic screws because the expiration dates on the labels are incorrect and later than the actual expiration 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. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically rated as Moderate (2).

Plain-English summary

Smith & Nephew, Inc. is recalling 100 units of D-RAD, 2.4MMX 20MM, S.T. Cortex Screws. 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 14MM07780R. The recall covers units distributed nationwide in the United States and internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore.

Consumers and healthcare providers should stop using the recalled screws and contact Smith & Nephew for further instructions or a replacement.

The recalled product

Product
D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Screws
Hazard
Affected units
100

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 14MM07780R

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.

See all 4 products in this recall →

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