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U.S. Department of Health and Human Services

Class 2 Device Recall Holder, Needle, Orthopedic

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  Class 2 Device Recall Holder, Needle, Orthopedic see related information
Date Initiated by Firm August 17, 2020
Create Date September 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-2999-2020
Recall Event ID 86290
510(K)Number K163142  
Product Classification Holder, needle; Orthopedic - Product Code HXK
Product Speed Stitch Needle Cassette
Code Information Model: OM-8850 Lot Numbers: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 & 2032526
Recalling Firm/
Manufacturer		 ArthroCare Corporation
7000 W William Cannon Dr Bldg 1
Austin TX 78735-8509
For Additional Information Contact Gary M. Smith
901-399-1970
Manufacturer Reason
for Recall		 Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On August 17,2020 the firm notified all its consignees via letter of the field action. They provided the following instructions: Please inspect your inventory and locate any devices from the listed product and batch numbers, and quarantine them immediately. " If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. If you have no product to return, please put an X in the appropriate location. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com or fax to +1-901-566-7975.
Quantity in Commerce 6,366 needles
Distribution Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and 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 = HXK and Original Applicant = ArthroCare Corporation
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