Z-0842-2022Class II

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Name: Z-0842-2022 Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Creator: Howmedica Osteonics Corp.
Published: 2022-01-14
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2022-01-14 / Open, Classified / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 on 2022-01-14. FDA classified it as Class II and gives the reason as "Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0842-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-14
Posted: 2022-03-31
Recalling firm: Howmedica Osteonics Corp
Product: Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Recall (UMDR) PFA 2902313 on 14th January 2022 to affected consignees. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 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. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to [email protected] / Fax: (866) 915-5064. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices back to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2902313 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. ****UPDATE 3/17/22: Urgent Medical Device Recall UPDATE issued on March 15, 2022, impacts consignees in the following countries due to the change in scope: U.S., Canada, China, Japan, UK, and Netherlands. However, consignees in Ireland, Spain, Germany, and Belgium, who originally received the UMDR, will also be notified of the UMDR UPDATE so they are made aware that they did not receive product that was non-conforming. UMDR UPDATE issued on March 15, 2022: 1. Please inform users of this Urgent Medical Device Recall UPDATE and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately che
Quantity in commerce: 92 units Update: 40 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, MD, MN, NC, NJ, NY, OH, OR, PA, TN, TX and the countries of Canada, China, Japan, Spain, UK, Netherlands, Germany & Belgium. ***Updated 3/17/22: U.S., Canada, China, Japan, UK, and Netherlands.
Product codes and lots: Lot Numbers: 89648801 89648802 89648803 89648804 89648805 GTIN: 04546540608475 ****UPDATE 3/17/22: Lot Number: 89648802 UDI: " (01)04546540608475(17)261020(10)89648802 Removed from scope of Recall: 89648801 89648803 89648804 89648805

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0842-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0842-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-31
Z-0843-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code LZO

K052718Class IIV40 Biolox Delta Ceramic Femoral HeadsHowmedica Osteonics Corp. / cleared 2005-10-27

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)