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Recall Observatory FDA recall evidence

Device product

Speed Stitch Needle Cassette

Z-2999-2020

August 17, 2020

Class II

Product summary

Firm
ArthroCare Corporation
Event
Event 86290
Status
Ongoing
Classification
Class II
Quantity
6,366 needles
Official record key
device-enforcement:Z-2999-2020

Official wording

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.

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    does not meet the specification