Smith & Nephew Orthopedic Nail May Detach During Surgery
Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.
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: This is an FDA Class II surgical device recall where the nail head may detach during implantation. No illnesses or injuries have been reported. Per the rubric, this qualifies as High (3) under 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smith & Nephew Orthopaedics Ltd. is recalling 47 units of the BHR SQUARE HEADED NAIL (catalog number 999908), an orthopedic surgical implant. The affected lot/batch codes are 20LW15962 and 20LW15963.
The nail head may become detached during surgery.
These nails have been distributed worldwide, including to the United States, United Kingdom, Norway, Canada, Australia, and New Zealand.
The recalled product
- Product
- smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
- Manufacturer
- Smith & Nephew Orthopaedics Ltd. (Aurora)
- Affected units
- 47
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 (2)
- Lot/Batch Codes: 20LW15962
- 20LW15963
Distribution
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