Z-2702-2020Class II

Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves -

Name: Z-2702-2020 Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves -
Creator: Smith & Nephew, Inc.
Published: 2020-06-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of 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/... on 2020-06-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2702-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-24
Posted: 2020-07-24
Recalling firm: Smith & Nephew, Inc.
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
Product code: HRX Arthroscope
Reason for recall: 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 tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 137 Lot 2042492; 130 Lot 2049408
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 codes and lots: Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2702-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2702-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-24

Product code HRX

K925573Class IIAcufex T-BarAcufex Microsurgical, Inc. / cleared 1993-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)