Agency classClass IOur severity:Severe FDA (Devices)·Z-2206-2012·Announced 2012-08-22

Synthes Hemostatic Bone Putty Recalled for Potential Ignition Risk

Synthes USA HQ, Inc. is recalling 8,853 packs of Hemostatic Bone Putty because the product may ignite if contacted with electrosurgical cautery systems during surgery.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural/functional defect in a medical device (potential ignition) that poses a significant risk of injury during surgery, meeting the criteria for a Severe rating.

Plain-English summary

Synthes USA HQ, Inc. is recalling 8,853 packs of Synthes(R) Hemostatic Bone Putty. The affected part numbers are 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. This product is indicated for use as a water-soluble implant material and for the control of bleeding from bone surfaces.

The recall is being issued because there is a potential for the Hemostatic Bone Putty to ignite if it comes into contact with electrosurgical cautery systems under certain conditions during surgery. The recall covers all lot numbers associated with the identified part numbers.

The product was distributed worldwide, including in the United States (specifically Washington, DC and the states of AK, AZ, CA, CT, FL, GA, ID, KS, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI) and Canada. Healthcare providers and facilities should stop using the affected product and contact Synthes USA HQ, Inc. for further instructions.

The recalled product

Product: Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
Manufacturer: Synthes USA HQ, Inc.
Category: Medical Device — Surgical Implant
Hazard: fire
burn-injury
Affected units: 8,853

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)

All lot numbers associated with the identified part numbers.

Distribution

Distributed in 27 states:

Same manufacturer · Synthes USA HQ, Inc.

See all →

Moderate
Synthes Electric Pen Drive Hand Switch Recalled for Labeling Error
FDA (Devices) · 2014-01-08
Moderate
Synthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
FDA (Devices) · 2013-12-18
Moderate
Synthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
FDA (Devices) · 2013-12-18
Severe
Synthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11
Moderate
Synthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
FDA (Devices) · 2013-12-11

Same hazard · fire