Zimmer Recalls Shoulder Surgery Drill Due to Labeling Error
Zimmer, Inc. is recalling 87 units of a shoulder surgery drill because the catalog number on the packaging did not match the actual product.
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, but the source text identifies the issue as a packaging and labeling discrepancy (incorrect catalog number) rather than a defect causing injury or illness. This aligns with the rubric for minor labeling errors.
Plain-English summary
Zimmer, Inc. is recalling 87 units of the Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. The recall was initiated because the product, which is intended for use during shoulder surgery, was packaged and labeled with an incorrect catalog number.
The specific units involved have catalog number 47-4307-031-00 and lot number 62071190. The source text indicates that the catalog number 47-4301-031-00 was actually packaged and labeled as 47-4307-031-00. These medical instruments were distributed nationwide to facilities in Texas, Florida, Mississippi, Michigan, Ohio, Kansas, Tennessee, Kentucky, Oklahoma, Utah, Colorado, California, Illinois, North Carolina, New Jersey, North Dakota, and Wisconsin.
Healthcare providers and facilities should check their inventory for this specific catalog and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by the recall notice.
The recalled product
- Product
- Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 87
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)
- Catalog number 47-4307-031-00
- lot 62071190
Distribution
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