Z-2999-2020Class II

Speed Stitch Needle Cassette

Name: Z-2999-2020 Speed Stitch Needle Cassette
Creator: ArthroCare Corporation
Published: 2020-08-17
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2020-08-17 / Open, Classified / root cause: supplier

FDA source

ArthroCare Corporation began a recall of Speed Stitch Needle Cassette on 2020-08-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2999-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-17
Posted: 2020-09-22
Recalling firm: ArthroCare Corporation
Product: Speed Stitch Needle Cassette
Product code: HXK Holder, Needle; Orthopedic
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.
Root cause tag: supplier
FDA 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2999-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2999-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-30	2020-09-21

Product code HXK

K163142Class IISpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and UnloaderArthroCare Corporation / cleared 2017-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)