Z-0143-2022Class II

6.5Mmx165mm Cannulated Screw

Name: Z-0143-2022 6.5Mmx165mm Cannulated Screw
Creator: Smith & Nephew, Inc.
Published: 2021-09-20
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2021-09-20 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of 6.5MMX165MM CANNULATED SCREW on 2021-09-20. FDA classified it as Class II and gives the reason as "The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded". 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-0143-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-20
Posted: 2021-10-19
Terminated: 2023-03-24
Recalling firm: Smith & Nephew, Inc.
Product: 6.5Mmx165mm Cannulated Screw
Product code: HWC Screw, Fixation, Bone
Reason for recall: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith & Nephew issued a customer letter via email dated September 20, 2021. Consignees are asked to inspect inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. Consignees must complete the enclosed response form, sign and send to [email protected]. Response form shall be completed even if there is no impacted product on hand.
Quantity in commerce: 5 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
Product codes and lots: Model 71106365S; Lot 20GT39417

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0143-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0143-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code HWC

K060736Class IISmith & Nephew 6.5Mm and 8.0Mm Cannulated ScrewsSmith & Nephew, Inc. / cleared 2006-04-18

China's FDA-registered implant bench is 151 establishments of 4,70415 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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)