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Recall Observatory FDA recall evidence

Device product

Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

Z-2702-2020

June 24, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 85984
Status
Ongoing
Classification
Class II
Quantity
137 Lot 2042492; 130 Lot 2049408
Official record key
device-enforcement:Z-2702-2020

Official wording

Reason: The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

Code information: Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT. Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT, & ZA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve