Z-1921-2023Class II

Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

Name: Z-1921-2023 Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Creator: Howmedica Osteonics Corp.
Published: 2023-05-03
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2023-05-03 / Open, Classified

FDA source

Howmedica Osteonics Corp. began a recall of Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 on 2023-05-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1921-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-03
Posted: 2023-06-14
Recalling firm: Howmedica Osteonics Corp
Product: Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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: Under Investigation by firm
Action: 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
Quantity in commerce: 2 units
Distribution: International distribution in the country of Ireland.
Product codes and lots: UDI-DI: 07613327188660; Lot Number: G7207242

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1921-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1921-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)