Z-0314-2022Class II

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

Name: Z-0314-2022 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Creator: Howmedica Osteonics Corp.
Published: 2021-10-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-10-15 / Open, Classified / root cause: packaging

FDA source

Howmedica Osteonics Corp. began a recall of 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 on 2021-10-15. FDA classified it as Class II and gives the reason as "There is a potential for the outer white Tyvek lid to debond from the sealed package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0314-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-15
Posted: 2021-11-30
Recalling firm: Howmedica Osteonics Corp
Product: 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Product code: JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Reason for recall: There is a potential for the outer white Tyvek lid to debond from the sealed package.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On 10/15/2021, Stryker issued Urgent Medical Device Recall notices to customers. Actions Needed: 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 recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form 5. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6. Please forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2812588
Distribution: Puerto Rico
Product codes and lots: UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0314-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0313-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-11-30
Z-0314-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-11-30

Product code JDG

K173499Class IIExeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics / cleared 2018-03-19

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)