Arrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.
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 is classified as FDA Class II and involves a risk of patient infection due to potential sterility assurance reduction, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrowhead DE LLC is recalling 4,171 units of the Arrow-LOK Implant. These medical devices are indicated for the fixation of osteotomies, arthrodeses, and reconstruction in the lesser toes following corrective procedures. The recall involves specific reference numbers, including 21-253519, 21-253522, and 27-253535, among others.
The recall was initiated because the implants did not undergo a required gamma radiation dose audit. This failure to audit could result in a potential reduction in sterility assurance, which may lead to patient infection. The affected units were distributed nationwide in the United States, specifically in the states of Vermont, Florida, Tennessee, New York, Georgia, Texas, and Hawaii.
Healthcare providers and patients who have received these implants should contact Arrowhead DE LLC for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for…
- Manufacturer
- Arrowhead DE LLC
- Affected units
- 4,171
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)
- REF/UDI-DI/Lot: 21-253519/00855967006035/24662119
- 242162
- 21-253522/00855967006042/24662122
- 242163
- 220702
- 21-253525/00855967006059/24662125
- 220703
- 242164
- 21-253528/00855967006066/24662128
- 242165
- 230704
- 21-253530/00855967006073/242166
- 230705
- 220705
- 21-253533/00855967006080/24662133
- 242167
- 230706
- 21-253535/00855967006097/24662135
- 242168
- 230707
Distribution
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