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Recall Observatory FDA recall evidence

Device product

ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

Z-0145-2021

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-0145-2021

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: 2020371 2020372 2020373 2020995 2030838 2035405 2044636 2048178

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