Speed Stitch Needle Cassette
FDA Recall Z-2999-2020 · Posted None
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Recalling FirmArthroCare Corporation
Recall StatusOpen, Classified
Product CodeHXK
Date Initiated2020-08-17
Product Quantity6,366 needles
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.
Firm 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 [email protected] or fax to +1-901-566-7975.
Root Cause
Mixed-up of materials/components
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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