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Recall Observatory FDA recall evidence

Device product

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

Z-1238-2024

January 24, 2024

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 93924
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1238-2024

Official wording

Reason: Products not sterilized, sterility cannot be confirmed

Code information: UDI: 10887587057262 Lot Number: 499P371

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility cannot be confirmed