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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is a prolonged surgical procedure, with no patient harm or reported injury.
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.
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