CLASS II ONGOING Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

Intertan 5 Nail 130deg recalled by Smith & Nephew Orthopaedics

Smith & Nephew Orthopaedics is recalling Intertan 5 Nail 130deg, distributed nationwide in the US. The recall was initiated on 22 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989

Quantity recalled17 units

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-1133-2022
FDA event ID: 90118
Recalling firm: Smith & Nephew Orthopaedics, Tuttlingen
Classification: Class II
Status: Ongoing
Recall initiated: 22 Apr 2022
FDA classified: 25 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Apr 2022	Recall initiated by company
25 May 2022	Classified by FDA	+33 days
1 Jun 2022	Published in enforcement report	+7 days

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

Reason for recall

Right nails were anodized, marked, and labelled as left nails and vice versa

Product as listed by the FDA

INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right

Where it was distributed

Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.

Nationwide California Colorado Georgia Indiana Missouri North Carolina Ohio Pennsylvania Tennessee Texas

Questions about this recall

Is Intertan 5 Nail 130deg recalled?

Yes. Smith & Nephew Orthopaedics recalled Intertan 5 Nail 130deg on 22 Apr 2022. The recall is Class II and its status is Ongoing. Recall number Z-1133-2022.

Why was it recalled?

Right nails were anodized, marked, and labelled as left nails and vice versa

Which lots are affected?

Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989

Where was it sold?

Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.

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.

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide