—#191999

Product

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

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052718
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 strykerortho2798@sedgwick.com / 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

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191999. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.