Z-1380-2021Class II

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm -

Name: Z-1380-2021 Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm -
Creator: Arthrex, Inc.
Published: 2021-03-11
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2021-03-11 / Terminated

FDA source

Arthrex, Inc. began a recall of Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and... on 2021-03-11. FDA classified it as Class II and gives the reason as "It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1380-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Posted: 2021-04-09
Terminated: 2024-10-29
Recalling firm: Arthrex GmbH
Product: Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Product code: HRS Plate, Fixation, Bone
Reason for recall: It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
FDA root cause: Under Investigation by firm
Action: A Recall notification letter titled, "URGENT: RECALL NOTIFCIATION" was sent to consignees on 03/11/2021 via email. The email sent to the consignees requested that the parts be returned. Additionally, the firm is currently awaiting all distributed units to be returned. The recalling firm requested that consignees immediately discontinue use, sale, and distribution of the product. Instructions were provided for Arthrex Agencies (North America), Arthrex Subsidiaries (LATAM and APAC), direct customers (EMEA), and Arthrex Subsidiaries (EMEA) as follows: Arthrex Agencies (North America): Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (LATAM and APAC): Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. The consignee is not required to notify patients of the product recall. Direct customers (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or [email protected]. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or [email protected]. The consignee is not required to notify patients of the product recall.
Quantity in commerce: 32 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
Product codes and lots: Part number: AR-13200T-15.0; Lot code:12135408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1380-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1380-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-09

Product code HRS

K032187Class IIAnthrex Titanium Opening Wedge Osteotomy SystemArthrex, Inc. / cleared 2003-09-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)