Achilles repair implant kits recalled over drill bits fusing during use
Medline is recalling 163 DEXLOCK Achilles Repair Implant Kits after multiple complaints of the drill bit fusing to the bushing within the drill guide during use.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."
Plain-English summary
DEXLOCK Achilles Repair Implant Kits, MAKT4520, are being recalled by Medline Industries, LP.
There have been multiple complaints of the drill bit fusing to the bushing or sleeve within the drill guide during use. The firm states that retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
The record lists 163 units in the United States, from lot 19019 with UDI-DI 10193489131703. Distribution was nationwide in the United States, in Alabama, Arkansas, Arizona, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Montana, North Carolina and New Jersey among other states. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is a prolonged surgical procedure, and no injuries are reported. Facilities should quarantine the affected lot and follow Medline's instructions.
The recalled product
- Product
- Deep-brand Select Tindora Net Wt. 12 oz. (340 g) KEEP FROZEN
- Manufacturer
- CHETAK NEW YORK LLC
- Affected units
- 3,509,532
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Lot: 24353
- 24360
- 25011
- 25031
- 25035
- 25049
- 25080
- 25084
- 25091
- 25106
- 25113
- 25116
- 25142
- 25145
- 25149
- 25168
- 25171
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
Same manufacturer · CHETAK NEW YORK LLC
See all →- CriticalFrozen punjabi tinda recalled after the product tested positive for Salmonella
FDA (Food) · 2025-12-17
- SevereNebivolol tablets recalled over cross contamination with other products
FDA (Food) · 2025-12-17
- SevereQuick Strip fabric bandages, 1 by 3 inch, recalled over open seals
FDA (Food) · 2025-12-17
- CriticalFrozen green channa recalled after testing positive for Salmonella
FDA (Food) · 2025-12-17
- CriticalFrozen sliced carrots recalled after testing positive for Salmonella
FDA (Food) · 2025-12-17
Same hazard · instrument failure
See all →- ModerateSpinal instrument sets recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- ModerateUniversal implant inserters recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- HighAngled punch awls recalled following failure of fusion system instruments
FDA (Devices) · 2025-09-17
- HighAngled screwdrivers recalled after fusion system instruments failed in the field
FDA (Devices) · 2025-09-17
- HighHemostatic Forceps Recalled Due to Clamp Breakage in Surgical Use
FDA (Devices) · 2025-03-19
Similar recalls
- HighMedline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk
FDA (Devices) · 2023-02-08
- HighMEDLINE ultrasound procedure kit connectors recalled due to insertion malfunction
FDA (Devices) · 2024-12-04
- HighBETTA LINK SR Knotless Implant Kit Drill Guides May Bend During Surgery
FDA (Devices) · 2023-07-12
- HighSurgical Implant Kit Recall: Incorrect Drill Guide Included
FDA (Devices) · 2022-10-26
- HighAd-Tech Drill Sleeve Guides Recalled for Potential Drill Bit Seizure
FDA (Devices) · 2019-09-25
- HighBETTA LINK LG Implant Drill Guide Bending Risk
FDA (Devices) · 2023-07-12