The Recall Desk
HighFDA (Devices)·Z-0100-2023·Announced 2022-10-26

Synthes SPEED implant recall: drill guide size mismatch in surgical kit

Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.

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: FDA Class II medical device recall with potential for significant intraoperative bone damage. No illnesses or injuries have been reported, but the risk of bone damage from incorrect drill hole placement during surgery warrants High severity.

Plain-English summary

Synthes (USA) Products LLC has recalled the SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 (Lot MSE210240, expires 7/1/2027), distributed nationwide in the United States.

The product is being recalled because the sterile kit contains an incorrect-size drill guide. This drill guide will not properly prepare the bone for the size of the implant included in the kit.

If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant.

The recalled product

Product
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Surgical implant
Hazard
  • bone-damage
  • surgical-site-injury
  • implant-misalignment

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)

  • UDI-DI (GTIN): 00810633020111 Lot/Expiry MSE210240 7/1/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category