Storage Case Design Flaw May Allow Reuse of Single-Use Surgical Instruments
Howmedica Osteonics Corp. is recalling HRIS Storage & Sterilization Cases (Part 6210-9-900) due to a design flaw that may allow reuse and resterilization of single-use, sterile instruments. This poses a contamination and infection risk.
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: FDA Class II medical device recall where the design flaw poses a risk of infection through reuse of single-use surgical instruments, with no reported illnesses or injuries to date. This meets the High-severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling the HRIS Storage & Sterilization Case and Tray (Part Number 6210-9-900) due to a design flaw. This product is used to store and sterilize Gray Revision Instruments used in orthopedic and revision surgical procedures.
The design of the storage case may lead to misuse of the Gray Revision Instruments it contains, specifically allowing reuse and resterilization of instruments that are designed to be used only once and are supplied in sterile packaging. Reusing single-use surgical instruments compromises sterility and increases the risk of contamination and infection.
The recall affects 630 units distributed worldwide, including to the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, the United Kingdom, and Venlo. All product lots manufactured since 2006 are included in this recall, identified by Part Number 6210-9-900 and UDI-DI 07613327217902.
Users of this product should stop use and contact Howmedica Osteonics Corp. regarding the recall.
The recalled product
- Product
- HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 630
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 (3)
- Part 6210-9-900
- UDI-DI: 07613327217902
- Lot#: All lots back to 2006.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. 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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