INSTRUMENT recallZ-1921-2023 · Howmedica Osteonics Corp. · initiated May 3, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT MEDICAL DEVICE RECALL notification letter dated 5/3/23 was 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 Urgent 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 to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the affected product in Table 1. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to [email protected] 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3238368; Please include Tracking information on the package. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing [email protected]. We regret any inconvenience this action may cause. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaini
Recall details
- Recall number
- Z-1921-2023
- Status
- Open, Classified
- Initiated by the company
- May 3, 2023
- Posted by the FDA
- Jun 14, 2023
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 2 units
- Product code
- LXH
- Distribution
- International distribution in the country of Ireland.
Product description
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Code information (models, lots, serial numbers)
UDI-DI: 07613327188660; Lot Number: G7207242
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INSTRUMENT 6364-8-026Howmedica Osteonics Corp. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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