FDAFDA · Food and drugs·Recall number Z-1238-2024
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
Published March 13, 2024 · Recall initiated: January 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Products not sterilized, sterility cannot be confirmed
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
- Lot
- UDI: 10887587057262 Lot Number: 499P371
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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