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Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2)… recallZ-2702-2020 · Smith & Nephew, Inc. · initiated Jun 24, 2020

Class II Open, Classified All recalls posted in July 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

Smith & Nephew issued Urgent Medical Device Recall Notice R-2020-12 dated June 24, 2020 via email and FedEx. to distributors, sales reps, hospitals or surgeons. Letter states reason for recall, health risk and action to take: Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected]. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected]. Expanded Recall: An updated FSN was sent on August 28, 2020 to customers that received the additional affected batch. The recall was expanded as a result of additional complaints.

Recall details

Recall number
Z-2702-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 24, 2020
Posted by the FDA
Jul 24, 2020
Recalling firm
Smith & Nephew, Inc.
Quantity
137 Lot 2042492; 130 Lot 2049408
Product code
HRX
FDA submissions
K925573
Distribution
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

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K925573 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page