PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported October 20, 2021

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 medium locking mechanism. Catalog Number: LSK 027

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Recall #
Z-0114-2022
Affected scope
1 unit
Initiated
September 1, 2021
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Flower Orthopedics Corporation recalled Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used wit… - a moderate-severity action.

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used wit… was recalled by Flower Orthopedics Corporation in October 20, 2021. Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure. Check the official notice for the remedy. Verify recall #Z-0114-2022 with the FDA Devices before acting.

The recall

Flower Orthopedics Corporation issued this moderate-severity FDA Devices recall-Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure.

Moderate
severity level
1 units
affected scope
Class II
classification
October 20, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0114-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 medium locking mechanism. Catalog Number: LSK 027

Reason for recall

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0114-2022
Date reported October 20, 2021
Date initiated September 1, 2021
Recalling firm Flower Orthopedics Corporation
Firm location Horsham, PA
Affected scope 1 unit
Distribution Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1 unit units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0114-2022) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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 medium locking mechanism. Catalog Number: LSK 027. Recalled by Flower Orthopedics Corporation. Units affected: 1 unit.
Why was this product recalled?
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Which agency issued this recall?
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0114-2022.
Where was the recalled product distributed?
Distribution: Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported October 20, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026