Smith & Nephew Recalls Mislabelled High Offset StikTite Coated Hip Stems
Smith & Nephew is recalling 9 units of hip stems where the outer label incorrectly identified the product as size "1" instead of the actual size "-1".
What this means for you
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, which typically corresponds to a moderate severity score. The hazard is a labeling error (mis-labeling) where the outer label does not match the internal product size, a risk that is generally considered moderate as it relies on user verification to prevent misuse.
Plain-English summary
Smith & Nephew, Inc. is recalling 9 units of the SMF(TM) High Offset StikTite(TM) Coated Stem 12/14 Taper -1H Size (Reference 713552511). 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 units 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 lot codes associated with the recall are 11CM01091T, 11EM12764T, 11EM12764U, 13MM16036B, 14GM13037D, 15MM09360A, 15MM10833A, 18CM24036, and 18EM15257.
Healthcare providers and patients should verify the size of the implanted or pending implant against the packaging. If the outer label indicates size "1" but the product is intended to be size "-1", the device should not be used and the facility should contact Smith & Nephew for instructions on return or replacement.
The recalled product
- Product
- smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 9
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 (8)
- 11CM01091T
- 11EM12764T
- 11EM12764U
- 13MM16036B
- 14GM13037D
- 15MM09360A
- 15MM10833A
- 18CM24036 & 18EM15257
Distribution
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.
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