Arrow-LOK Implant recall
Arrowhead DE LLC recalled Arrow-LOK Implant on August 26, 2026 because of implant did not undergo required gamma radiation dose audit. It was sold nationwide.
Why it was recalled
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
What's recalled
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 fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.
Quantity: 4,171
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Arrowhead DE LLC, Peachtree City, GA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI. - Status
- Ongoing
- Recall number
- Z-2958-2026
- Source
- U.S. Food and Drug Administration
More medical devices recalls
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.