Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-35…
Arrowhead DE LLC · Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamm…
Open FDA's page for this record- Cfres ID
- 221452
- Product res number
- Z-2958-2026
- Event date initiated
- 2026-06-23
- Event date posted
- 2026-08-14
- Recall status
- Open, Classified
- Res event number
- 99383
- Product code
- HTY
- Firm FEI number
- 3008817603
- Recalling firm
- Arrowhead DE LLC
- Address 1
- 401 Westpark Ct Ste 200 401 Westpark Ct
- Address 2
- Ste 200
- City
- Peachtree City
- State
- GA
- Postal code
- 30269-3572
- Additional info contact
- 901-853-4366
- Root cause description
- Process change control
- Product quantity
- 4,171
- Distribution pattern
- US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
- Product description
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.
- Code info
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.
- 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
- K numbers
- K112675
- Harmonized identifiers (openFDA)
- Device name
- Pin, Fixation, Smooth
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- K number
- K103623, K013888, K141004, K964087, K925301, K011522, K250646, K831005, K253325, K073311, K211439, K041355, K955806, K121008, K003659, K201838, K133950, K051605, K974291, K112254, K083490, K012161, K940673, K170418, K070561, K863734, K041157, K173051, K203698, K014305, K050275, K183228, K033717, K061607, K081097, K122415, K874913, K250315, K905337, K960483 +165 more
- Registration number
- 3011301313, 2249615, 1221934, 3013176080, 3026032087, 3008951116, 3011127597, 3042903229, 3006460162, 2431166, 1834331, 3014252644, 2029275, 3010041511, 3010462278, 9611274, 3007539489, 3019269298, 3005061536, 3011874600, 1835831, 3004635447, 3004748528, 3014315669, 1226183, 3016851379, 1833920, 3008110533, 1048735, 3009826895, 3003604053, 1319660, 1450662, 2936485, 3034676720, 3017980495, 2437731, 3010470577, 3010370500, 1833986 +246 more
- FEI number
- 3011301313, 1221934, 3013176080, 3026032087, 3008951116, 3011127597, 3042903229, 3006460162, 3014252644, 1000116116, 3010041511, 3010462278, 3007539489, 3019269298, 3008647423, 3002757549, 3005061536, 3011874600, 3004635447, 3004748528, 3014315669, 3016851379, 3002807113, 3008110533, 1048735, 3009826895, 3003604053, 1450662, 2936485, 3034676720, 3017980495, 3001617730, 3010470577, 3010370500, 3010813691, 3006395932, 3009110133, 3005827567, 3007125392, 3001236277 +246 more