Synthes Orthopedic Guide Blocks Recalled for Incorrect Labeling
Synthes, Inc. is recalling 180 Guide Blocks for the Volar Distal Radius Plate System due to incorrect package labeling. The physical parts are correctly marked, but the packaging may identify the wrong side.
What this means for you
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: This is classified as a Moderate severity recall (Score 2) because it involves a minor labeling error on the packaging of a medical device. The source text explicitly states that the laser etching on the parts is correct, indicating the physical device is not defective, which aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Synthes, Inc. is recalling 180 units of Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). These are orthopedic surgical instruments used in medical procedures. The recall was initiated because the products were found to be labeled incorrectly on the outside packaging.
Specifically, part number 03.111.600 (Right) was found in packages labeled as part number 03.111.601 (Left). The affected units are from lot number 10-5147. The FDA notes that the laser etching on the physical parts themselves correctly denotes the orientation, meaning the internal marking is accurate despite the packaging error.
The affected products were distributed nationwide in the United States and in Bermuda. Healthcare providers and facilities that have these specific part numbers and lot numbers should stop using them and contact Synthes, Inc. for instructions on return or replacement. Patients who have already had surgery using these instruments should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 180
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 (3)
- part no. 03.111.600
- lot no. 10-5147
- and part no. 03.111.601
Distribution
Distributed nationwide across the United States.
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