Z-2733-2020Class II

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -

Name: Z-2733-2020 Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -
Creator: Arthrex, Inc.
Published: 2020-06-24
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2020-06-24 / Terminated / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a... on 2020-06-24. FDA classified it as Class II and gives the reason as "Screws provided in packaging are 5mm shorter than intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2733-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-24
Posted: 2020-07-29
Terminated: 2021-02-16
Recalling firm: Arthrex GmbH
Product: Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Screws provided in packaging are 5mm shorter than intended
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arthrex initiated recall on 06/24/2020. The notification states the following: 1 . Immediately discontinue use, sale, and distribution of the product. 2. Direct Customers (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 3. Arthrex Subsidiaries (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 4. Arthrex Subsidiaries (APAC): a. Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or [email protected].
Quantity in commerce: 28 units
Distribution: International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Product codes and lots: Batch Number: 10706233 UDI Number:00888867056411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2733-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2733-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-29

Product code HRS

K141478Class IIArthrex Fracture Plates and ScrewsArthrex, Inc. / cleared 2014-07-08

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)