Z-2152-2024Class II

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

Name: Z-2152-2024 HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Creator: Howmedica Osteonics Corp.
Published: 2024-05-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2024-05-23 / Open, Classified / root cause: design

FDA source

Howmedica Osteonics Corp. began a recall of HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 on 2024-05-23. FDA classified it as Class II and gives the reason as "The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2152-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-23
Posted: 2024-06-18
Recalling firm: Howmedica Osteonics Corp
Product: HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Root cause tag: design
FDA root cause: Device Design
Action: On May 23, 2024 MEDICAL DEVICE RECALL letters were sent to customers. Actions needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage at your facility to determine if any Gray Revision Instruments from the affected product list in Table 2 have been removed from sterile packaging (Gray Revision Instruments are single-use, sterile-packaged manual surgical instruments). 3. If any Gray Revision Instruments have been removed from sterile packaging, discard/dispose of those instruments. 4. Gray Revision Instruments found within their sterile packaging may be used as intended (single-use, sterile-packaged). 5. Do not use the HRIS Storage & Sterilization Case and Tray or the Gray Revision Instrument System Accessory Tray/Case to re-process (re-sterilize, clean, or re-use) the Gray Revision Instruments, which are single-use, sterile-packaged manual surgical instruments. 6. You may continue to use the HRIS Storage & Sterilization Case and Tray or the Gray Revision Instrument System Accessory Tray/Case for all other instruments as intended. 7. Complete and sign the enclosed Medical Device Recall Business Reply Form and email to [email protected]/ fax (844) 412-9273. 8. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. Please assist us in meeting our regulatory obligation by emailing back the attached Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physic
Quantity in commerce: 630 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
Product codes and lots: Part 6210-9-900, UDI-DI: 07613327217902, Lot#: All lots back to 2006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2152-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18
Z-2153-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)