Z-0644-2022Class II

32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032

Name: Z-0644-2022 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Creator: Howmedica Osteonics Corp.
Published: 2021-12-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-12-21 / Open, Classified / root cause: packaging

FDA source

Howmedica Osteonics Corp. began a recall of 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 on 2021-12-21. FDA classified it as Class II and gives the reason as "There is a potential for the outer Tyvek lid to de-bond 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-0644-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-21
Posted: 2022-02-16
Recalling firm: Howmedica Osteonics Corp
Product: 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE RECALL UPDATE notification letter dated 12/21/21 was sent to customers. Recommendations for Patient Follow-Up Patients should continue to be followed per the normal protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol. 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 follow up 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 UPDATE 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. Complete and sign the enclosed Urgent Medical Device Recall UPDATE Business Reply Form 5. 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 UPDATE to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Att. Regina Short (Quality Manager) / PFA# 2812588 Stryker Global Quality & Operations Tullagreen Building, IDA Business & Technology Park, Carrigtwohill, Cork, Ireland T45 HE42 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall UPDATE Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. We regret any
Quantity in commerce: 8 units
Distribution: Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
Product codes and lots: UDI: 07613327012842; Lot Number: 87327407

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0644-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0644-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-16
Z-0645-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-16

Product code LPH

K121308Class IIHip SystemsHowmedica Osteonics Corp. / cleared 2012-07-30

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)