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U.S. Department of Health and Human Services

Class 2 Device Recall VLP(R) MiniMod Small Bone Plating System

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 Class 2 Device Recall VLP(R) MiniMod Small Bone Plating Systemsee related information
Date Initiated by FirmDecember 11, 2017
Create DateJanuary 19, 2018
Recall Status1 Terminated 3 on June 22, 2018
Recall NumberZ-0396-2018
Recall Event ID 78826
510(K)NumberK132886 
Product Classification Plate, fixation, bone - Product Code HRS
Productsmith&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.
Code Information Lot number 15GM08498C
FEI Number 1020279
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer 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
FDA Determined
Cause 2		Mixed-up of materials/components
ActionThe 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 FieldActions@smith-nephew.com 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 FieldActions@smith-nephew.com or call 901-566-7084.
Quantity in Commerce2 units
DistributionUS Distribution to states of: MI, GA, and OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRS
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