Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1028-2019·Announced 2019-03-27

Smith & Nephew Recalls Mislabelled Hip Stem Implants Due to Size Error

Smith & Nephew is recalling 58 hip stem implants because the outer label incorrectly identified the product as size "1" instead of "-1".

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 a labeling error (size misidentification) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Smith & Nephew, Inc. is recalling 58 units of the SMF(TM) Standard Offset Stiktite(TM) Coated Stem 12/14 Taper -1 Size (Ref 713552510). The recall was initiated after complaints indicated that the outer label incorrectly identified the product as size "1" instead of the actual size "-1" contained within the package.

The affected products were distributed in the United States (California, Tennessee, North Carolina, Arkansas, Indiana, Florida, and Missouri) and internationally in Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, and Spain. The specific batch numbers involved are 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035, and 18CM08027.

This is an FDA Class II recall. Healthcare providers and facilities should verify the size of the implants in their inventory against the packaging labels to ensure the correct size is used during surgical procedures.

The recalled product

Product: smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
Affected units: 58

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 (6)

Batch Numbers: 11AM15163U
11AM15184T
11CM01097U
15MM06466
16EM13018
16EM13035 & 18CM08027

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Smith & Nephew, Inc.

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