Z-0396-2018Class II

smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating...

Name: Z-0396-2018 smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating...
Creator: Smith & Nephew, Inc.
Published: 2017-12-11
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-12-11 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD... on 2017-12-11. FDA classified it as Class II and gives the reason as "Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa". 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-0396-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Posted: 2018-01-19
Terminated: 2018-06-22
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: The firm, Smith & Nephew, Inc., sent an "Urgent Medical Device Recall Notice" letter dated December 11, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory, locate unused devices and quarantine immediately; if you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out; return product, and complete and return the response form by email to [email protected] or fax to 901-566-7975 even if you have not product to return. If you have any questions or concerns regarding this recall please contact [email protected] or call 901-566-7084.
Quantity in commerce: 2 units
Distribution: US Distribution to states of: MI, GA, and OH.
Product codes and lots: Lot number 15GM08498C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0396-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0396-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19
Z-0397-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19

Product code HRS

K132886Class IISmith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. / cleared 2014-02-04

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)