🔍 RecallPedia

Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.

Class I - Dangerous
🏥 Medical Devices Recalled: February 16, 2015 Flower Orthopedics Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Flower Orthopedics Corporation
Reason for Recall:
Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.

Product Codes/Lot Numbers:

All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126

Distribution:

Distributed in: VA, TX, IL, OK, PA, CA, NY, KY, FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1314-2015

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Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1

Flower Orthopedics

Class I - Dangerous

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