Device product
TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
Z-0155-2021
Product summary
- Event
- Event 86462
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 263,874 (total)
- Official record key
device-enforcement:Z-0155-2021
Official wording
Reason: 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
Code information: Batch Numbers: 2013151 2013152 2013903 2016145 2017808 2018788 2019884 2019885 2025277 2027457 2031003 2031002 2031054 2031055 2033509 2033508 2034401 2038771 2042570 2042752 2048296 2049809 2050955 2053788 2056330 2056872
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
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
breach of the sterile barrier