Z-0786-2022Class II

Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a...

Name: Z-0786-2022 Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a...
Creator: Wright Medical Technology, Inc.
Published: 2022-02-15
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-02-15 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System on 2022-02-15. FDA classified it as Class II and gives the reason as "An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw". 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-0786-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-15
Posted: 2022-03-15
Terminated: 2022-10-05
Recalling firm: Wright Medical Technology Inc
Product: Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Product code: HRS Plate, Fixation, Bone
Reason for recall: An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified the foreign competent authority via email on 2/15/2021 which included a copy of the recall letter. Once the foreign competent authority approves the recall, the recall letter will be sent to the foreign consignee. The recall letter is dated 2/15/2022 and describes the product, the issue, potential risks, and the actions needed. The actions included (1) informing individuals within their organization who need to be aware of this device recall; (2) immediately check all stock areas and/or operating room storage to determine if there is any affected product; (3) quarantine and discontinue use of the recalled device; (4) complete the business reply form and a Stryker representative will contact the customer to arrange for return and replacement of the device; (5) inform Stryker if the device has been distributed to other organizations. If so, provide contact details so that Stryker can inform the recipient appropriately. If the consignee is a distributor, they are responsible for notifying the affected customers; and (6) inform Stryker of any adverse events concerning the use of the device.
Quantity in commerce: 1 package
Distribution: International distribution to the country of France.
Product codes and lots: Lot #73967511638696

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0786-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0786-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-15

Product code HRS

K090692Class IIOrtholoc 2.0/2.4 Plate SystemWrightmedicaltechnologyinc / cleared 2009-05-08

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)