Z-1133-2022Class II

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

Name: Z-1133-2022 INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Creator: Smith & Nephew Orthopaedics GmbH
Published: 2022-04-22
License: https://open.fda.gov/license/

Smith & Nephew Orthopaedics AG / initiated 2022-04-22 / Open, Classified / root cause: labeling and UDI

FDA source

Smith & Nephew Orthopaedics GmbH began a recall of INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right on 2022-04-22. FDA classified it as Class II and gives the reason as "Right nails were anodized, marked, and labelled as left nails and vice versa". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1133-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-22
Posted: 2022-05-25
Recalling firm: Smith & Nephew Orthopaedics AG
Product: INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Product code: JDS Nail, Fixation, Bone
Reason for recall: Right nails were anodized, marked, and labelled as left nails and vice versa
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action.
Quantity in commerce: 17 units
Distribution: Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
Product codes and lots: Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1133-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1133-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-25

Product code JDS

K040212Class IITrigen IntertanSmith & Nephew, Inc. / cleared 2004-02-20

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)