| | Class 2 Device Recall ArrowLOK Implant |  |
| Date Initiated by Firm | June 23, 2026 |
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| Date Posted | August 14, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2958-2026 |
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| Recall Event ID |
99383 |
| 510(K)Number | K112675 |
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| Product Classification |
Pin, fixation, smooth - Product Code HTY
|
| 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. |
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| Code Information |
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
|
| FEI Number |
3008817603
|
Recalling Firm/
Manufacturer |
Arrowhead DE LLC
401 Westpark Ct Ste 200
Peachtree City GA 30269-3572
|
| For Additional Information Contact |
901-853-4366 |
|---|
Manufacturer 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 2 | Process change control |
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| 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 |
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| Quantity in Commerce | 4,171 |
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| Distribution | US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
|
|---|
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HTY
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