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U.S. Department of Health and Human Services

Class 2 Device Recall TWINFIX TI 2.8mm HS SUTURE ANCHOR WITH TWO 28" DURABRAID SUTURE (USP 2)

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  Class 2 Device Recall TWINFIX TI 2.8mm HS SUTURE ANCHOR WITH TWO 28" DURABRAID SUTURE (USP 2) see related information
Date Initiated by Firm December 30, 2019
Create Date February 19, 2020
Recall Status1 Terminated 3 on May 11, 2021
Recall Number Z-1273-2020
Recall Event ID 84748
510(K)Number K152566  K972326  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Code Information Batch numbers: 2010547, 2025137, 2036695, 50763859, & 50773071. Part Number 72200796. UDI 10600147.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact Sean Reynolds
978-749-1173
Manufacturer Reason
for Recall		 Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
FDA Determined
Cause 2		 Package design/selection
Action Smith Nephew "Urgent Medical Device Recall Notice R-2019-22" letter dated December 30, 2019. Customers were advised to: 1.Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com or fax to 901-566-7975. Please Note  even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units
Distribution Worldwide distribution  US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MBI and Original Applicant = ORTHOPAEDIC BIOSYSTEMS, LTD.
510(K)s with Product Code = MBI and Original Applicant = SMITH & NEPHEW, INC.
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