• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 60076
Product Type Biologics
Status Ongoing
Recalling Firm Surgical Tissue Network, Inc. dba TissueNet
City Orlando
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Products were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
UltraC1 or C2, Cervical is labeled in part: "***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***UltraC1, Cervical***FD57506, 6mm Small label: "***ID:***UltraC1, Cervical***FD57507, 7mm Small label: "***ID:***UltraC1, Cervical***FD57508, 8mm Small label: "***ID:***UltraC2, Cervical***FD57607, 7mm Product ID: FD57506, 6mm TN4211610002, TN4211610003, TN4211610004, TN4211610005, TN4211610006 TN4211610007, TN4211610008 Product ID: FD57507, 7mm TN4211610009, TN4211610010, TN421161001, TN4211610012, TN4211610013 TN4211610014 Product ID: FD57508, 8mm TN4211610015 Product ID: FD57607, 7mm TN4211610029, TN4211610030, TN4211610031, TN4211610032, TN4211610033 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 19 ea B-1637-12
Cancellous Crushed is labeled in part: "***Tissue ID:***Description: Cancellous Crushed***Size 15cc-4mm-10mm***Product Code FD55315R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Cancellous Crushed***FD55315R EXP:***TissueNet 800-465-8800***" Product ID: TN4211610036, TN4211610037, TN4211610038, TN4211610039, TN4211610040, TN4211610041, TN4211610042, TN4211610043, TN4211610044, TN4211610045, TN4211610046, TN4211610047, TN4211610048, TN4211610049, TN4211610050 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 15 ea B-1638-12
Cancellous Crushed is labeled in part: "***Tissue ID:***Description: Cancellous Crushed***Size 30cc-4mm-10mm***Product Code FD55330R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Cancellous Crushed***FD55330R EXP:***TissueNet 800-465-8800***" Product ID: TN4211610051, TN4211610052, TN4211610053, TN4211610054, TN4211610055, TN4211610056, TN4211610057, TN4211610058, TN4211610059, TN4211610060, TN4211610061, TN4211610062, TN4211610063, TN4211610064, TN4211610065 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 15 ea B-1639-12
Ultrafill DBM Human is labeled in part: "***Tissue ID:***Description: Ultrafill DBM Human***Size 10cc***Product Code HM53010***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Ultrafill DBM Human***HM53010 EXP:***TissueNet 800-465-8800***" Product ID: TN4211610093, TN4211610094, TN4211610095, TN4211610096, TN4211610097 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 5 ea B-1640-12
Ultrafill DBM Human is labeled in part: "***Tissue ID:***Description: Ultrafill DBM Human***Size 5cc***Product Code HM53005***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Ultrafill DBM Human***HM53005 EXP:***TissueNet 800-465-8800***" Product ID: TN4211610098, TN4211610099, TN4211610100, TN4211610101, TN4211610102, TN4211610103, TN4211610104, TN4211610105, TN4211610106, TN4211610107 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 10 ea B-1641-12
Mineralized Bone is labeled in part: "***Processed by: TissueNet***7022 TPC Dr Ste 400***Orlando, FL 32822***Sterilized By: T106^(r) {SAL 10-6}***Tissue ID:***Description: Mineralized Bone***Size 5cc***Product Code MB50050***Expiration***Freeze Dried: Store at 10 C - 37 C***Donated Human Tissue Allograft***Single Patient Use Only***". Full Product Description: Mineralized Bone .125-.85mm 5cc Product ID: TN4211610153, TN4211610154, TN4211610155, TN4211610156, TN4211610158, TN4211610159, TN4211610160, TN4211610161, TN4211610162, TN4211610163, TN4211610164, TN4211610165, TN4211610166, TN4211610167, TN4211610168, TN4211610169, TN4211610170, TN4211610171, TN4211610172, TN4211610173, TN4211610174, TN4211610175, TN4211610176, TN4211610177, TN4211610178, TN4211610179, TN4211610180 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 27 ea B-1642-12
Fashioned UltraBTB is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraBTB***Size***Product Code FF99050***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraBTB***FF99050 EXP:***TissueNet 800-465-8800***" Full Product Description: Fashioned UltraBTB 10x10mm Product ID: TN4211610073, TN4211610074, TN4211610075, TN4211610076 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 4 ea B-1643-12
Fashioned UltraAchilles is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraAchilles***Size***Product Code FF94355***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraAchilles***FF94355 EXP:***TissueNet 800-465-8800***" Full Product Description: Fashioned Achilles 9mm Product ID: TN4211610071, TN4211610072 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 2 B-1644-12
UltraTibialis (Anterior) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraTibialis (Anterior)***Size***Product Code FF84230***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraTibialis (Anterior) ***FF84230 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Tibialis Anterior Product ID: TN4211610077, TN4211610078 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 2 ea B-1645-12
UltraP (Peroneus Longus) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraP (Peroneus Longus)***Size***Product Code FF93500***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraP (Peroneus Longus)***FF93500 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Peroneus Longus Product ID: TN4211610079, TN4211610080 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 2 ea B-1646-12
Ultra Tibialis (Posterior) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Ultra Tibialis (Posterior)***Size***Product Code FF84231***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Ultra Tibialis (Posterior)***FF84231 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Tibialis Posterior Product ID: TN4211610081, TN4211610082 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 2 ea B-1647-12
Ultra Semi-T (Semitendinosus) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Ultra Semi-T (Semitendinosus)***Size***Product Code FF83100***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Ultra Semi-T (Semitendinosus)***FF83100 EXP:***TissueNet 800-465-8800***" Product ID: TN4211610083, TN4211610084 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 2 ea B-1648-12
Fascia Lata, Large is labeled in part: "***Tissue ID:***Description: Fascia Lata, Large***Size:***Product dimension***Product Code FD73520***EXPIRATION***Freeze Dried: Store at 10 c - 37 c***Sterilization Method: T106 Terminal Sterilization system***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***ID:***Fascia Lata, Large***FD73520 EXP:***TissueNet 800-465-8800***" Product ID: TN4211610087, TN4211610088 Class II Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. 2 ea B-1649-12
-
-