Recall Z-2958-2026 ยท HTY Pin, Fixation, Smooth
Arrowhead DE LLC
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.
| Date | Aug 14, 2026 (initiated Jun 23, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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 |
| Quantity | 4,171 |
| Distribution | US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112675 | ARROW-LOK DIGITAL SYSTEM Arrowhead Medical Device Technologies, LLC, Dec 12, 2011 |