PlainRecordsArrow-LOK Implant…
- Reason
- Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
- Status
- Ongoing
- Distribution
- US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
- Enforcement report date
- Aug. 26, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Arrowhead DE LLC
- 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. Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.
- Reason
- Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
- Distribution pattern
- US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
- Quantity
- 4,171
- Codes and 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
- Recall started
- June 23, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Pin, Fixation, Smooth
- Root cause (FDA)
- Process change control
- What the company told customers
- 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
- Recall number
- Z-2958-2026
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.”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., FDA enforcement report, 2026-08-26. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Pin, Fixation, Smooth
Distributed in (FDA's record): Florida Georgia Hawaii New York Tennessee Texas Vermont and nationwide
This recall among the others
- FDA's enforcement report came 64 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-2958-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2958-2026, Aug. 26, 2026. "Arrow-LOK Implant." PlainRecords, https://plainrecords.com/recall/device/z-2958-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections