INTERTAN 1.5 nail orthopedic implants recalled due to reversed left-right labeling
Smith & Nephew is recalling INTERTAN 1.5 nails because right nails were marked and labeled as left nails, and vice versa. This mislabeling could lead to incorrect surgical placement.
What this means for you
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: This is an FDA Class II recall of an orthopedic implant where left-right labeling reversal poses a direct risk of harm through incorrect surgical placement. No illnesses or injuries are reported in the source, limiting the score to 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smith & Nephew Orthopaedics GmbH is recalling INTERTAN 1.5 NAIL products (13mm × 42cm, both left and right variants) due to a manufacturing defect in marking and labeling. Right nails were anodized, marked, and labeled as left nails, and left nails were marked and labeled as right nails.
This reversal could result in surgeons inadvertently using the wrong implant orientation during orthopedic procedures, potentially leading to improper fracture fixation and patient harm.
The recall affects 17 units distributed to healthcare facilities in Georgia, Ohio, Indiana, Texas, Colorado, Missouri, Tennessee, California, North Carolina, Pennsylvania, and internationally to Canada and Australia. The affected batch numbers are 21LT56988 (product number 71676627) and 21LT56989 (product number 71676628).
If you have received these implants, contact Smith & Nephew immediately and verify correct orientation before use. Healthcare providers should review inventory and confirm actual left and right orientation matches all labeling and packaging.
The recalled product
- Product
- INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
- Manufacturer
- Smith & Nephew Orthopaedics GmbH
- Hazard
- mislabeling
- left-right-reversal
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 (4)
- Product number: 71676627 (DI: 00885556131633)
- Batch Number: 21LT56988
- 71676628 (DI: 00885556040027)
- Batch number: 21LT56989
Distribution
Distributed nationwide across the United States.
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