Howmedica Gray Revision Instrument Tray Recalled for Design Enabling Instrument Reuse
Howmedica is recalling the Gray Revision Instrument System Accessory Tray/Case due to a design flaw that may enable reuse and re-sterilization of single-use, sterile-packaged instruments.
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 involving a medical device storage case with a design defect that could enable reuse of single-use sterile instruments, creating a contamination risk. No illnesses, injuries, or hospitalizations have been reported. Per the severity rubric, this qualifies as Score 3 (High) for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling the Gray Revision Instrument System Accessory Tray/Case, Part Number 6210-9-910, affecting 209 units. The design of the storage and sterilization case may lead to misuse of the Gray Revision Instruments, specifically the re-use and re-sterilization of instruments that are intended to be single-use and sterile-packaged.
The affected product was distributed worldwide to the United States and internationally including 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 lots manufactured since 2006 are included in this recall.
Users should review their instrument handling procedures to prevent misuse of single-use instruments. Healthcare facilities should discontinue use if concerned about proper instrument handling and contact Howmedica Osteonics Corp. for guidance on corrective actions or replacement of affected cases.
The recalled product
- Product
- Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 209
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 6210-9-910
- UDI-DI: 07613327217780
- 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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