Flower Lag Screw Kit drill bits missing AO connect feature recalled
Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
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 2/5 (Moderate).
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a missing functional feature that may cause procedural delay rather than direct patient harm.
Plain-English summary
Flower Orthopedics Corporation is recalling Flower Lag Screw Kit 2.7 mm (Catalog Number LSK 027) due to drill bits missing the AO connect feature. The affected kits are intended for use with various Flower orthopedic plating sets including the Small and Medium Implant Set, Ankle Plating Set, Rear Foot/Calcaneus Plating Set, and Upper Extremity Plating Set.
The missing AO connect feature on the drill bits may result in delay of surgical procedures. The affected lot number 2013003419 was distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Nevada, Ohio, Texas, and Virginia.
Healthcare providers using this product should contact Flower Orthopedics Corporation regarding replacement or corrected kits. No injuries or illnesses related to this issue have been reported.
The recalled product
- Product
- Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the…
- Manufacturer
- Flower Orthopedics Corporation
- Affected units
- 1
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 (1)
- Lot Number: 2013003419 Unique Identifier: 00840118103688
Distribution
Part of a larger recall action
This product is one of 4 recalled by Flower Orthopedics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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