CLASS I Device recall · Reported 22 Aug 2012 · FDA Enforcement Report

Synthes(R) Hemostatic Bone Putty recalled by Synthes USA HQ

Synthes USA HQ is recalling Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, distributed in 27 states. The recall was initiated on 5 Jul 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lot numbers associated with the identified part numbers.

Quantity recalled8,853 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2206-2012
FDA event ID: 62592
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class I
Status: Terminated
Recall initiated: 5 Jul 2012
FDA classified: 16 Aug 2012
Reported: 22 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Jul 2012	Recall initiated by company
16 Aug 2012	Classified by FDA	+42 days
22 Aug 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution -- US, including Washington, DC and 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 the country of Canada.

Alaska Arizona California Connecticut District of Columbia Florida Georgia Idaho Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina Nebraska New Hampshire New York Ohio

Questions about this recall

Why was it recalled?

There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

Which lots are affected?

All lot numbers associated with the identified part numbers.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Synthes USA HQ

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18 Dec 2013Device	CLASS II	Synthes Trochanteric Fixation Nail As part of the Synthes recalled	Synthes USA HQ	Labeling Errors	Nationwide
11 Dec 2013Device	CLASS II	Synthes Soft Tissue Retractor Small Extendible recalled	Synthes USA HQ	Device Malfunction	Nationwide
11 Dec 2013Device	CLASS II	Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ	Synthes USA HQ	Other	Nationwide

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