The Recall Desk

Hazard

Improper Fit recalls

36 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
36
Critical
0
Severe
5
Most recent
2025-06-25

Of the 36 improper fit recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (14%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all improper fit recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–36 of 36

  • ModerateFDA (Devices)·Z-0942-2013·2013-03-20

    Synthes Titanium Midface Distractor Recalled Due to Fit Issues

    Synthes USA is recalling 596 Titanium Midface Distractors because oversized tabs may prevent footplates from fitting properly.

    Product
    Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0878-2013·2013-03-06

    Medacta Recalls Versafitcup Impacting Rings for Fit Issues

    Medacta USA is recalling Versafitcup Impacting Rings because they may not fit properly in the implant shell, potentially causing surgical delays and complications.

    Product
    Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2483-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices because they may fit too loosely or too tightly with mating components.

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2473-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2482-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.

    Product
    00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2478-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to intraoperative dislodging.

    Product
    12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2012·2012-10-10

    Biomet Recalls OptiLock T15 AO Drivers Due to Fit Issues

    Biomet, Inc. is recalling 363 units of OptiLock T15 AO Drivers because they may not properly lock into specified screw heads.

    Product
    Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2012·2012-10-10

    Biomet Recalls OptiLock Screw Inserters Due to Fit Issues

    Biomet is recalling 268 OptiLock 2.7 mm Screw Inserters because they may not properly lock into screw heads, posing a risk of improper fixation.

    Product
    Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2012·2012-08-22

    Nico BrainPath Sheath Recall Due to Incorrect Length Labeling

    Nico Corp. is recalling 15 BrainPath sheaths because 50mm units were mislabeled as 60mm, causing improper fit.

    Product
    13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2200-2012·2012-08-22

    Nico BrainPath Sheaths Recalled for Incorrect Length Labeling

    Nico Corp. is recalling 20 BrainPath sheaths because 50mm units were mislabeled as 60mm, creating a risk of improper fit during use.

    Product
    13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator
    Category
    Medical Device
    Distribution
    1 state