FDA Medical Device Recalls (openFDA)
ArthroCare Corporation: Speed Stitch Needle Cassette
- Recall number
- Z-2999-2020
- Recalling firm
- ArthroCare Corporation
- Product
- Speed Stitch Needle Cassette
- Status
- Open, Classified
- Initiated
- 2020-08-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K163142"]
- PMA numbers
- not on file
- Product code
- HXK
- Firm FEI
- 3010813691
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28