Zimmer Recalls Reverse Glenosphere and Other Devices Due to Packaging Error
Zimmer is recalling specific lots of medical devices because they were packaged in incorrect outer cartons, though the product labels are correct.
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 hazard is limited to incorrect outer carton packaging with correct product labels, fitting the criteria for minor labeling/packaging errors.
Plain-English summary
Zimmer, Inc. is initiating a lot-specific recall of the Trabecular Metal Reverse Glenosphere, CPT Hip Stem, and Versys Build-Up Block medical devices. The recall is due to reports that these products were packaged in the incorrect outer carton. The source text confirms that the product labels and patient labels are correct.
The recall affects 25 units of the Trabecular Metal Reverse Glenosphere 36mm (Part 00-4349-036-11, Lot 62393502). These devices were distributed worldwide, including to specific US states and Germany. There have been 71 distribution events, and 7 units have been returned, leaving 64 affected units in the field subject to removal.
Healthcare providers and patients should check their inventory and records for the specific part and lot numbers listed in the recall notice. If the devices are found, they should be removed from use and returned to Zimmer, Inc. according to the company's instructions.
The recalled product
- Product
- Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 25
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)
- Part 00-4349-036-11
- Lot 62393502
Distribution
Part of a larger recall action
This product is one of 3 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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