The Recall Desk

FDA (Devices) recall action 63204

Orthovita, Inc., dBA Stryker Orthobiologics. recalled 13 products on 2013-06-05

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products
13
Announced
2013-06-05
Critical
0
Units
1,413

Why these products were recalled

There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–13 of 13

  • HighFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 411 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 35 units of the Aliquot Beveled Needle because the catheter may break during removal. The issue is attributed to user error, and the correction involves updating the Directions for Use.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Diamond Needle Recall for Catheter Breakage

    Stryker Orthobiologics is recalling 19 units of the Aliquot Diamond Needle due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage Risk

    Stryker Orthobiologics is recalling 17 units of the Aliquot Plunger, 8", due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 164 units of the Aliquot Plunger Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage Risk

    Stryker Orthobiologics is recalling five Aliquot Reamer units because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 78 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error

    Stryker Orthobiologics is recalling 69 Aliquot Catheters due to reported breakage during vertebroplasty procedures attributed to use errors.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error Revision

    Stryker Orthobiologics is recalling 27 Aliquot Catheters to revise instructions after reported breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Distribution
    33 states