ArthroCare Corporation Speed Stitch Needle Cassette Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Speed Stitch Needle Cassette
Brand
ArthroCare Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
ArthroCare Corporation is recalling Speed Stitch Needle Cassette due to 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 titani. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026