Recall Z-2958-2026
Arrowhead DE LLC · initiated June 23, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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; 21-253540/00855967006110/242169; 21-253545/00855967006127/242170; 21-253550/00855967006134/24662150; 21-353513/00855967006004/24662113, 242160; 21-353516/00855967006011/24662116, 230701, 242161; 27-253519/00855967006028/24662719, 242171; 27-253522/00855967006141/242172; 27-253525/00855967006158/242173; 27-253528/00855967006165/242174; 27-253530/00855967006172/242175; 27-253533/00855967006189/24662733, 242176; 27-253535/00855967006196/24662735, 242177
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.
FDA-determined cause: Process change control
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
Details
- Recall number
- Z-2958-2026
- Initiated
- June 23, 2026
- Posted by FDA
- August 14, 2026
- Product code
- HTY – Pin, Fixation, Smooth
- Quantity
- 4,171
- Distribution
- US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
- Recalling firm
- Arrowhead DE LLC, Peachtree City, GA