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U.S. Department of Health and Human Services

Class 2 Device Recall INTEGRA SURFIX ALPHA Screwdriver Torx 10

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 Class 2 Device Recall INTEGRA SURFIX ALPHA Screwdriver Torx 10see related information
Date Initiated by FirmJanuary 04, 2022
Create DateFebruary 01, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0548-2022
Recall Event ID 89382
510(K)NumberK073375 
Product Classification Plate, fixation, bone - Product Code HRS
ProductINTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Code Information UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information ContactDave Sunder
978-749-1440
Manufacturer Reason
for Recall		The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA Determined
Cause 2		Process control
ActionThe firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.
Quantity in Commerce8 units (US)
DistributionUS Nationwide distribution in the states of CA 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HRS
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