Speed Stitch Needle Cassette
Reported: September 30, 2020 Initiated: August 17, 2020 #Z-2999-2020
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.
Details
- Recalling Firm
- ArthroCare Corporation
- Units Affected
- 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
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Speed Stitch Needle Cassette. Recalled by ArthroCare Corporation. Units affected: 6,366 needles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2020. Severity: Moderate. Recall number: Z-2999-2020.
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