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Recall Observatory FDA recall evidence

Device product

HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706

Z-0170-2021

September 09, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 86462
Status
Ongoing
Classification
Class II
Quantity
263,874 (total)
Official record key
device-enforcement:Z-0170-2021

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: 2013923 2013951 2013987 2016163 2017827 2017828 2018645 2018644 2018753 2020065 2021559 2024738 2024839 2025433 2025435 2025436 2025367 2027468 2027435 2027501 2029263 2029398 2031090 2031091 2034427 2034428 2035537 2035538 2035539 2036725 2041201 2041202 2045870 2045869 2048392 2048394 2048395 2049915 2049916 2052172 2052173 2052174 2052175 2052177 2048393 2056427 2056428

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

    reason.labeling_packaging · v1.0.0

    incomplete seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier