Z-1855-2017Class II

D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Name: Z-1855-2017 D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Creator: Smith & Nephew, Inc.
Published: 2017-03-09
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-03-09 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic on 2017-03-09. FDA classified it as Class II and gives the reason as "The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1855-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Posted: 2017-04-18
Terminated: 2019-08-21
Recalling firm: Smith & Nephew, Inc.
Product: D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Product code: HWC Screw, Fixation, Bone
Reason for recall: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact [email protected]. For questions regarding this recall call 978-749-1440.
Quantity in commerce: 19 units
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore
Product codes and lots: Batch number 15KM05493

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1855-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1854-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1855-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1856-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1857-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18

Product code HWC

K132296Class IID-Rad Smart PackSmith & Nephew, Inc. / cleared 2014-01-07

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