Zimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation
Zimmer Biomet is recalling 1,257 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.
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: The recall is classified as FDA Class II. The hazard involves a lack of sterilization validation for a medical instrument, which presents a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,257 units of the Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510. The recall was initiated because the products lack an adequate sterilization validation.
The affected products were distributed nationwide in the United States and to 16 foreign countries, including Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, and Venezuela. The recall covers a wide range of lot numbers, including 251059, 254986, 203752, and many others listed in the agency documentation.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected instrument cases and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,257
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, 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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