Bone fixation screws recalled over a labeling error on one lot
Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.
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: Scored 2 under the minor labeling criterion: the record cites a labeling error with no stated consequence or reported harm.
Plain-English summary
The BIOSURE HA SCREW, 6MM x 20MM, a threaded metallic bone fixation fastener, is being recalled by Smith & Nephew, Inc.
The reason given in the enforcement record is removal of the affected lot of screws due to a labeling error.
The record lists 168 units, of which 83 are in the United States and 85 outside it, across model numbers 72201768 and 72204389, UDIs 03596010611642 and 00885554036572, and batch numbers 51315219 and 51306803. US distribution covered Alabama, California, Colorado, Florida, Iowa, Illinois, Kentucky, Minnesota, North Carolina, Nebraska, New York, Oklahoma, Tennessee, Texas and Utah. The FDA has classified the action as Class II.
The record cites a labeling error without describing its nature or a consequence, and states no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Manufacturer
- Smith & Nephew, Inc.
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)
- Model No. 72201768
- 72204389
- UDI: 03596010611642
- 00885554036572
- Batch No. 51315219
- 51306803.
Distribution
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