Speed Stitch Needle Cassette
- Company
- Arthrocare Corporation
- Recall Initiated
- August 17, 2020
- Recall Number
- Z-2999-2020
- Quantity
- 6,366 needles
- Firm Location
- Austin, TX
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.
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
Lot / Code Info
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
Root Cause
Mixed-up of materials/components
Action Taken
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.