Zimmer Shoulder System Reamer Guide recalled for plastic breakage
Zimmer is recalling the Off-Axis Comprehensive Shoulder System Small Reamer Guide due to plastic guides catching and breaking during reaming procedures.
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 an FDA Class II recall. No hospitalizations, deaths, or reported injuries are mentioned in the source text—only five complaints of device breakage. The hazard is a mechanical failure during a surgical procedure that could potentially cause harm, but no adverse health consequences are documented.
Plain-English summary
Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide (Model/Catalog Number 110040240) nationwide. Five complaints have been received reporting that plastic guides were catching during reaming, leading to breakage. The affected lot numbers are 099457 and 099458, with a total of 474 units distributed.
Affected patients should contact their healthcare provider or Zimmer, Inc. to discuss their treatment options and whether their device may have been affected. Clinicians using this product should be aware of the potential for plastic guide breakage and take appropriate precautions during shoulder reaming procedures.
The recalled product
- Product
- Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- Manufacturer
- Zimmer, Inc.
- Affected units
- 474
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 (5)
- Lot Code: Model No. 110040240
- UDI-DI (01)00889024681965(17)350601(10)099457
- Lot Number 099457 Model No. 110040240
- UDI-DI (01)00889024681965(17)350712(10)099458
- Lot Number 099458
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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