Regeneration Technologies, Inc. Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Brand
Regeneration Technologies, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
2250274 2250275 2250276 2443591 2443592 2443593 2443594 2443595 2444941 2444942 2444943 2444944 2444945 2444946 2444947 2444948 2444949 2444950 2446231 2446232 2446233 2446234 2446235 2446236 2446237 2446238 2446239 2446240 2000898 2000899 2000900 2000901 2000902 2000903 2000952 2000953 2000954 2000955 2000956 2000957 2000958 2000959 2000960 2000961 2000962 2000963 2000964 2000965 2000966 2000967 2000968 2000969 2250269 2250270
Regeneration Technologies, Inc. is recalling Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regenerat due to The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors canno. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
Recommended Action
Per FDA guidance
Notification sent to all consignees by FedEx. 10/14/2005
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026