Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-25354
FDA device recall Z-2958-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Arrowhead DE LLC
- Reason for recall
- Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
- Action taken
- On 6/23/2026 customers were phoned and informed to return affected implants. On 7/7/2026, recall notices were mailed to risk managers who were asked to do the following: 1) Cease use, distribution, and quarantine affected product. 2) Contact firm customer service to obtain instructions for returning product. 3) Email mail tracking numbers to firm. 4) Complete and return the acknowledgement and receipt form. Questions can be directed to the firm at 470-419-1429
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- HTY
- Quantity affected
- 4,171
- Distribution
- US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
- Date initiated
- 2026-06-23
- Date posted
- 2026-08-14
- Location
- Peachtree City, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW-LOK DIGITAL SYSTEM (K112675) | Arrowhead Medical Device Technologies, LLC | 2011-12-12 |