The Recall Desk
HighFDA (Devices)·Z-1698-2021·Announced 2021-06-09

T25 Cannulated Screwdrivers May Break During Surgical Procedures

T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits may break at the driver tip during use, extending surgery time and requiring additional imaging to identify fragments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical device that may break during use, creating a risk of harm through extended surgery and potential fragment retention. No injuries or hospitalizations have been reported; the hazard is risk-based rather than incident-based.

Plain-English summary

Flower Orthopedics Corporation is recalling T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300). These screwdrivers are designed for inserting orthopedic screws with T25 driving features in diameters of 5.5mm, 6.5mm, and 7.3mm.

The screwdrivers may break at the driver tip along the shaft near the handle during use. If breakage occurs, fragments may remain in the surgical site, extending surgery time and requiring additional x-ray imaging to locate and identify the fragments.

This recall affects 47 units distributed nationwide to healthcare facilities in Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Pennsylvania, North Carolina, and Virginia. The affected lot numbers are 2003320898, 1810220041, 1802220008, 1802220005, and 1711220035 (UDI: 00840118110853).

If you have received this product, verify the lot number on your inventory. Do not use the affected screwdrivers and contact Flower Orthopedics Corporation with any questions about the recall.

The recalled product

Product
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Manufacturer
Flower Orthopedics Corporation
Category
Medical Device — Surgical Instruments
Hazard
  • device-breakage
  • retained-fragments

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 (5)

  • Lot Numbers: 2003320898
  • 1810220041
  • 1802220008
  • 1802220005
  • 1711220035 UDI: 00840118110853

Distribution

Distributed nationwide across the United States.

Related recalls

Same category