Zimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation
Zimmer Biomet is recalling 92 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, which poses a risk of harm (infection) but the source text does not report specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 92 units of the Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509. The recall is due to a lack of adequate sterilization validation for these medical devices.
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. Specific lot numbers associated with the recall include 262549, 266083, 1441011, M642860, 2881015, 3021022, 3081051, 2591050, 2771027, 3231028, MJ54320, MJ54330, MJ54350, and MJ54340.
This recall is classified as Class II by the FDA. Healthcare providers and facilities should stop using these instrument cases and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 92
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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