Z-2999-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- August 17, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,366 needles
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.
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
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