CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew

Smith & Nephew is recalling Meta-tan Lag/compression Screw Kit, distributed nationwide in the US. The recall was initiated on 18 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034

Quantity recalled75

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-1806-2025
FDA event ID: 96586
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 18 Mar 2025
FDA classified: 19 May 2025
Reported: 28 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Mar 2025	Recall initiated by company
19 May 2025	Classified by FDA	+62 days
28 May 2025	Published in enforcement report	+9 days

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

Reason for recall

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

Product as listed by the FDA

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Where it was distributed

Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.

Nationwide Alabama Arizona California Florida Iowa Kentucky Louisiana Massachusetts Missouri North Carolina New Hampshire New Jersey New Mexico Nevada New York Ohio Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034

Where was it sold?

Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.

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

More recalls from Smith & Nephew

All 258

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew	Smith & Nephew	Other	DE
24 Dec 2025Device	CLASS II	Biosure HA Screw Threaded metallic bone fixation fastener recalled	Smith & Nephew	Labeling Errors	Nationwide
11 Dec 2024Device	CLASS II	Bioraptor Suture Anchors recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
13 Nov 2024Device	CLASS II	Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew	Smith & Nephew	Other	TN
6 Nov 2024Device	CLASS II	Leigon Oxinium Constrained Nonporous Femoral Component, Size 3 Left recalled	Smith & Nephew	Packaging Defects	TX

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide