FDAFDA · Food and drugs·Recall number Z-0150-2021
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Published October 28, 2020 · Recall initiated: September 9, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA
- Lot
- Batch Numbers: 2012768 2013311 2012721 2013998 2016127 2018633 2018634 2019989 2020049 2021384 2021453 2023181 2023223 2023335 2025106 2025286 2026922 2025140 2026921 2026923 2025339 2027417 2027452 2029072 2029363 2030909 2030910 2030911 2030985 2030983 2030984 2032785 2033372 2033373 2034382 2034383 2034384 2035515 2035516 2035517 2035518 2036275 2036276 2039986 2038899 2039421 2039422 2040069 2040070 2040071 2044789 2044790 2044791 2050884 2049652 2049653 2050885 2055771 2055772 2056306 2048187 2056871 2056307
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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