Recall Z-2999-2020— ArthroCare Corporation
Class II · Ongoing
Class II FDA medical device recall by ArthroCare Corporation, initiated 2020-08-17. It names one FDA 510(k) clearance: K163142. Product: Speed Stitch Needle Cassette. 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..
- Recalling firm
- ArthroCare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-08-17
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Speed Stitch Needle Cassette
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.