Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System reamer guides (Model 110040242) due to plastic guides that can catch and break during reaming. Five complaints have been received.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device where a structural defect (plastic guide breakage during use) poses a risk of harm. No injuries or hospitalizations have been reported in the source text, and the hazard is device malfunction during surgical use, placing it at High severity.
Plain-English summary
Zimmer, Inc. is recalling 429 units of the Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide (Model No. 110040242) distributed nationwide in the United States. The plastic guides in these devices can catch during reaming procedures, leading to breakage.
Five complaints have been received identifying this issue. The affected lot numbers are 099471, 099473, 099474, and 099475.
Healthcare providers and patients who have received this device should contact Zimmer, Inc. or their healthcare provider for guidance on whether the device remains safe for use or if replacement is needed.
The recalled product
- Product
- Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- Manufacturer
- Zimmer, Inc.
- Affected units
- 429
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 (9)
- Lot Code: Model No. 110040242
- UDI-DI (01)00889024681989(17)350601(10)099471
- Lot Number 099471 Model No. 110040242
- UDI-DI (01)00889024681989(17)350614(10)099473
- Lot Number 099473 Model No. 110040242
- UDI-DI (01)00889024681989(17)350804(10)099474
- Lot Number 099474 Model No. 110040242
- UDI-DI (01)00889024681989(17)350806(10)099475
- Lot Number 099475
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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