—#182377

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

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K925573
Affected lot / code info: Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408

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

Root cause (FDA determination)

Process design

Action the firm took

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 FieldActions@smith-nephew.com. 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 FieldActions@smith-nephew.com. 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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

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

Timeline

Recall initiated: 2020-06-24
Posted by FDA: 2020-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182377. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.