HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthr

FDA device recall Z-1000-2024 · posted 2024-02-06 · Open, Classified

Recall details

Recalling firm

Howmedica Osteonics Corp.

Reason for recall

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Action taken

Stryker issued Urgent Medical Device Recall (UMDR) PFA 3285098 was issued by third party Sedgwick on 22/DEC/2023 via UPS 2-day air. OUS customer notification will be issued at the country level. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Correction 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. Dispose of all affected products listed in the Part and Lot Number Attachment (PFA 3285098). 4. Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form. " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4742@sedgwick.com / Fax: (866) 723-2482 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 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. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the correction, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com

Root cause

Package design/selection

Status

Open, Classified

Product code

LXH

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa,

Date initiated

2023-12-22

Date posted

2024-02-06

Location

Mahwah, NJ