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Use caution Medical device recall · FDA · Published April 15, 2021

Flower Orthopedics T25 Screwdrivers: Risk of Breakage During Surgery

Flower Orthopedics recalls T25 Cannulated Screwdrivers (CSD 025) in Guide Wire Kits (GWK 300) that may break during surgery, causing longer procedures and additional x-rays. Affected units have specific lot numbers.

🇺🇸 FDA recall #Z-1698-2021Medical deviceFlower Orthopedics ›
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Recalling firmFlower Orthopedics Corporation100 Witmer Rd Ste 280 · Horsham, PA 19044-2647
✎ GovInfoNow plain-language explainer

Flower Orthopedics is recalling T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) because they can break during surgery. This breakage may extend surgery time and require additional x-rays to locate the broken pieces. Read more at govinfonow.com/recall/62782-flower-orthopedics-t25-screwdrivers-risk-of-breakage-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/62782-flower-orthopedics-t25-screwdrivers-risk-of-breakage-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1698-2021

Cite this page

“Flower Orthopedics T25 Screwdrivers: Risk of Breakage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62782-flower-orthopedics-t25-screwdrivers-risk-of-breakage-during-surgery. Based on FDA recall #Z-1698-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1698-2021%22&limit=1).

The FDA announced on April 15, 2021, that Flower Orthopedics Corporation is recalling T25 Cannulated Screwdrivers packaged in Guide Wire Kits due to the risk of breakage. The agency classified this as a Class II recall.

How to tell if you have it

  • Brand: Flower Orthopedics
  • Product: T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300)
  • Product Code: GWK 300
  • Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035
  • UDI: 00840118110853
  • Units affected: 47

The hazard

According to the FDA, the cannulated screwdrivers may break at the driver tip along the shaft. This failure can extend surgery time and require additional x-rays to identify fragments from the breakages.

Context

GovInfoNow's records show Flower Orthopedics Corporation has issued five other recalls since July 8, 2020. Other recent recalls of similar products include the Intuitive Surgical da Vinci S/Si Mega Needle Driver Recall (Dec. 9, 2025), the Olympus PK Cutting Forceps Recall (Feb. 25, 2026), and the HFD100 Head Fixation Device Recall (Dec. 8, 2025).

How to tell if you have this one

Check for Guide Wire Kits (GWK 300) with lot numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035. The product is intended for inserting screws with diameters of 5.5mm, 6.5mm, and 7.3mm.

  • Brand
    Flower Orthopedics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Numbers

    Identify if your Guide Wire Kit (GWK 300) has one of the listed lot numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Colorado, Florida, Georgia, Illinois, Indiana, North Carolina, Pennsylvania, Virginia.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Apr 15, 202112. FDA classified it Class II: Jun 1, 202123. Published in FDA’s Enforcement Report: Jun 9, 202134. FDA terminated the recall: Nov 12, 202142021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1698-2021 (April 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1698-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA