Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1857-2017·Announced 2017-04-26

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

Smith & Nephew is recalling 197 units of D-RAD locking 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, but the source text identifies the issue as a labeling error regarding expiration dates without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination where no harm has been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 197 units of D-RAD, S.T. Locking Screws, T7, sterile, in five specific sizes. The recall involves specific batch numbers for each size, including RES 74692410, RES 74692412, RES 74692416, RES 74692422, and RES 74692424.

The reason for the recall is that the expiration dates printed on the product labeling are incorrect. The actual expiration dates for these devices are earlier than the dates indicated on the labels. This discrepancy could lead to the use of expired medical devices.

The affected products were distributed nationwide in the United States and internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore. Healthcare providers and facilities should check their inventory for these specific batch numbers and stop using the affected devices. Consumers are advised to contact their healthcare provider if they have had these specific screws implanted.

The recalled product

Product: D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Screws
Hazard: mis-labeling
expired-device
Affected units: 197

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 (3)

Batch numbers: (a) RES 74692410: 15GM13481
15JM17474
15JM17475 (b) RES 74692412: 15EM010131

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 →

Same manufacturer · Smith & Nephew, Inc.

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