Brasseler USA Recalls Mislabelled Steinmann Pins for Bone Fracture Fixation
Brasseler USA is recalling 103 tubes of Steinmann Pins that were incorrectly labeled as threaded pins instead of smooth pins.
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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error that could lead to the use of the wrong medical device, but no injuries or illnesses are reported in the source text.
Plain-English summary
Brasseler USA I Lp is recalling 103 packaged and labeled tubes of KM168-39-76 Single Diamond Smooth Steinmann Pins. Each tube contains 6 pins. The product is used for the internal fixation of large bone fractures.
The recall was initiated because the tubes were labeled with incorrect product labels. Specifically, the smooth pins were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins. This labeling error could lead to the use of the wrong type of pin during a medical procedure.
The affected products were distributed in Arizona, Arkansas, and Florida. The specific lot number for the recalled items is NR8ZR. Healthcare providers and patients should check their inventory and records for these specific product codes and lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
- Manufacturer
- Brasseler USA I Lp
- Hazard
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 (1)
- Lot Number NR8ZR
Distribution
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