ArthroCare Speed Stitch Needle Cassettes Recalled for Potential Breakage
ArthroCare is recalling Speed Stitch Needle Cassettes because a supplier error may have resulted in needles made of titanium instead of stainless steel, posing a risk of breakage during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of breakage during use, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ArthroCare Corporation is recalling 6,366 units of Speed Stitch Needle Cassettes (Model OM-8850). The recall is due to a supplier error where raw material was inadvertently mixed, resulting in some needles being made of commercially pure titanium rather than the specified 304 stainless steel.
The use of titanium needles does not meet the product specifications and could potentially cause the needles to break during use. The affected lot numbers are 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239, and 2032526.
The products were distributed domestically to numerous US states and internationally to various countries including Australia, Germany, France, and the United Kingdom. Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected cassettes.
The recalled product
- Product
- Speed Stitch Needle Cassette
- Manufacturer
- ArthroCare Corporation
- Hazard
- Affected units
- 6,366
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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