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U.S. Department of Health and Human Services

Class 2 Device Recall OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE

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  Class 2 Device Recall OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE see related information
Date Initiated by Firm September 09, 2020
Create Date October 21, 2020
Recall Status1 Open3, Classified
Recall Number Z-0151-2021
Recall Event ID 86462
510(K)Number K151105  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE
-Absorbable Suture anchor
Product Number: 72201994
Code Information Batch Numbers: 2012769 2013999 2016154 2021495 2023224 2025101 2026924 2027418 2029364 2030912 2030913 2033496 2036691 2049654 2053758 2050886 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
150 Minuteman Rd
Andover MA 01810-1031
Manufacturer Reason
for Recall		 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
FDA Determined
Cause 2		 Equipment maintenance
Action Smith & Nephew issued Urgent Medical Device Recall letter (R-2020-19) FSN on September 9, 2020 via email or overnight mail to customers that received affected products. Letter states reason for recall, health risk, and action to take: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 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. 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 263,874 (total)
Distribution Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA
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 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) Database 510(K)s with Product Code = MAI and Original Applicant = Smith & Nephew, Inc.
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