CLASS II ONGOING Device recall · Reported 5 Aug 2020 · FDA Enforcement Report

T-F1X0 RCG Drill Pac Drill & Sleeves recalled by Smith & Nephew

Smith & Nephew is recalling Smith & Nephew T-F1X0 RCG Drill Pac Drill & Sleeves, distributed nationwide in the US. The recall was initiated on 24 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408

Quantity recalled137 Lot 2042492; 130 Lot 2049408

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2702-2020
FDA event ID: 85984
Recalling firm: Smith & Nephew, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2020
FDA classified: 24 Jul 2020
Reported: 5 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Surgical Instruments

Timeline

24 Jun 2020	Recall initiated by company
24 Jul 2020	Classified by FDA	+30 days
5 Aug 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Colorado Delaware

Questions about this recall

Is T-F1X0 RCG Drill Pac Drill & Sleeves recalled?

Yes. Smith & Nephew recalled T-F1X0 RCG Drill Pac Drill & Sleeves on 24 Jun 2020. The recall is Class II and its status is Ongoing. Recall number Z-2702-2020.

Why was it 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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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