Z-0167-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 9, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 263,874 (total)
Product Description
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
Reason for Recall
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
Distribution Pattern
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
Code Information
Batch Numbers: 2013959 2016246 2017861 2018756 2019936 2021510 2023286 2024791 2025371 2027465 2027498 2027403 2029347 2031019 2031087 2031153 2033535 2035497 2035534 2037188 2037148 2038325 2039607 2041068 2042774 2044894 2046452 2048384 2048385 2049906 2051015 2051016 2052167 2052166 2056074 2056423 2056424 2057383