—#200484

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: UDI-DI: 07613327188660; Lot Number: G7207242

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com 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 soprodexpreports@stryker.com. 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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: International distribution in the country of Ireland.

Timeline

Recall initiated: 2023-05-03
Posted by FDA: 2023-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200484. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.