Smith & Nephew Recalls 70 Undersized Modular Hip Neck Components
Smith & Nephew is recalling 70 modular hip neck components because the taper is undersized due to manufacturing errors.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device (undersized taper) which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Smith & Nephew Inc. is recalling 70 units of the 12/14 Taper High Offset Neck (Reference 71352112). These modular necks are intended for use with Smith & Nephew stems and 12/14 femoral components only.
The recall was initiated because the modular necks were manufactured out of specification by a vendor, resulting in an undersized taper. The affected units were distributed nationwide in the United States, including California, Florida, Georgia, Illinois, Indiana, Massachusetts, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington, as well as in Canada.
Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the return or replacement of these specific devices.
The recalled product
- Product
- 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 70
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 (12)
- Lot Numbers: 12FTM0017A
- 12FTM0017B
- 12FTM0017C
- 12FTM0019A. 12FTM0019B
- 12FTM0019C
- 12FTM0019D
- 12FTM0020A
- 12FTM0020B
- 12FTM0020C
- 12FTM0021A
- 12FTM0021B
- and 12FTM0021C
Distribution
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