ArthroCare recalls Speed Stitch Needle Cassette model OM-8850 with specific lot numbers due to potential needle breakage from improper material composition.
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.
ArthroCare is recalling Speed Stitch Needle Cassettes (model OM-8850) with certain lot numbers because some needles may be made of titanium instead of 304 stainless steel. This could cause needles to break during use, potentially leading to injury.
The recall is due to a supplier error where some needles were made from commercially pure titanium instead of 304 stainless steel. This material difference could cause needles to break during use, potentially leading to injury.
Users of Speed Stitch Needle Cassettes (model OM-8850) with specific lot numbers are affected. People using these products for medical procedures are most at risk if needles break during use.
Check the product label for model OM-8850 and lot numbers listed: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239, and 2032526.
Look for model OM-8850 and lot numbers listed in the recall notice.
Due to a supplier error where some needles were made from commercially pure titanium instead of 304 stainless steel, which could cause needles to break during use.
The recall notice does not specify a remedy, so check the product label for model OM-8850 and lot numbers to see if it is affected.
Yes, if needles break during use, it could lead to injury. However, the recall indicates this is a low-risk issue.
We’ve drafted a message you can send ArthroCare to request your refund or repair — edit it as you like.
Subject: Recall Z-2999-2020 — ArthroCare ArthroCare Hello, I own a ArthroCare that is covered by recall Z-2999-2020 from ArthroCare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
