Zimmer Recalls Hip and Shoulder Devices Packaged in Incorrect Cartons
Zimmer is recalling specific lots of hip and shoulder devices due to incorrect outer packaging. Product labels are correct, but the outer cartons were wrong.
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: This is a Class II recall involving a packaging error where the product labels are correct. It fits the rubric for minor labeling/packaging issues without reported injuries.
Plain-English summary
Zimmer, Inc. is initiating a lot-specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices. The recall is due to reports that these products were packaged in the incorrect outer carton. The product labels and patient labels on the devices themselves are correct.
The affected items are identified by Part 00-7871-001-10 and Lot 62359872. The recall involves three units. Distribution was worldwide, including the United States and Germany, with 71 distribution events recorded. Seven units have been returned, leaving 64 affected units in the field subject to removal.
Healthcare providers and patients should verify the lot numbers of their devices. If the devices match the recalled lot, they should contact Zimmer, Inc. for instructions on removal or replacement.
The recalled product
- Product
- Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 3
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)
- Part 00-7871-001-10 Lot 62359872
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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