Z-1360-2016Class II

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or...

Name: Z-1360-2016 Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or...
Creator: Arthrex, Inc.
Published: 2016-01-11
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2016-01-11 / Terminated / root cause: sterility

FDA source

Arthrex, Inc. began a recall of Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of... on 2016-01-11. FDA classified it as Class II and gives the reason as "Potential for a component contained in the Implant System to be non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1360-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-04-08
Terminated: 2019-07-24
Recalling firm: Arthrex GmbH
Product: Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Potential for a component contained in the Implant System to be non-sterile.
Root cause tag: sterility
FDA root cause: Other
Action: On 01/22/2016, all distributors and end user facilities were sent an Urgent Medical Device Voluntary Recall letter by Arthrex, Inc. The firm is voluntarily recalling and replacing the referenced device. Immediately discontinue distributing and use of the indicated product and return to Arthrex. Additionally the Recall Acknowledgement of Receipt card should be completed and returned. Contact Customer Service at 800-934-4404 for replacement and return information.
Quantity in commerce: 117 devices
Distribution: Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
Product codes and lots: Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1360-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1360-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08

Product code HRS

K031666Class IIArthrex Fiberwire Button Repair Kit, Model Ar-8920Ds/ar-8921DsArthrex, Inc. / cleared 2003-11-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)