Hazard

Loosening recalls

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

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2021-09-29

Of the 11 loosening recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all loosening 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.

1–11 of 11

HighFDA (Devices)·Z-2510-2021·2021-09-29
Aesculap Univation X System knee implant devices recalled for potential loosening
Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.
Product
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F ME
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1855-2020·2020-05-13
Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws
Nobel Biocare is recalling 215 Snappy Abutment 5.5 CC RP 3 mm units because they may contain incorrect screws that could loosen.
Product
Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to resto
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1853-2020·2020-05-13
Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
Nobel Biocare is recalling 239 units of Temporary Abutment Engaging CC RP components because packages may contain incorrect screws that could loosen.
Product
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to res
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1852-2020·2020-05-13
Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
Nobel Biocare is recalling 236 units of temporary dental implant abutments because packages may contain an incorrect screw that could loosen.
Product
Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1854-2020·2020-05-13
Nobel Biocare Recalls Dental Abutments Due to Incorrect Screw Risk
Nobel Biocare is recalling 227 Esthetic Abutment CC RP 1.5 mm units because they may contain incorrect screws that could loosen.
Product
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1857-2020·2020-05-13
Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws
Nobel Biocare is recalling 478 Temporary Snap Abutments because packages may contain incorrect screws that could loosen, requiring retightening.
Product
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacem
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1856-2020·2020-05-13
Nobel Biocare Universal Base Abutments Recalled for Incorrect Screws
Nobel Biocare is recalling 238 Universal Base CC RP 1.5 mm abutments because they may contain incorrect screws that could loosen.
Product
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1717-2019·2019-06-12
OMNIBotics iBlock Cutting Guide Recalled for Failure to Lock During Surgery
OMNIlife science Inc. is recalling 9 OMNIBotics iBlock Cutting Guides because they may not lock onto the iBlock Saw Guide as intended and could loosen during use.
Product
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2017·2017-02-08
Synthes Radial Head Prosthesis Recalled for Potential Stem Loosening
Synthes (USA) Products LLC is recalling 50,311 units of the Radial Head Prosthesis System because the radial stem may loosen post-operatively at the stem bone interface.
Product
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1265-2016·2016-04-06
Biomet Vanguard XP Knee System Recall for Sizing Defect
Biomet is recalling Vanguard XP Knee System porous femoral components because the AP dimension may be oversized, potentially causing loosening and revision surgery.
Product
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1266-2015·2015-03-18
Zimmer Persona Trabecular Metal Tibial Plate Recall for Loosening Complaints
Zimmer, Inc. is recalling Persona Trabecular Metal Tibial Plates due to increased complaints of loosening and radiolucent lines.
Product
Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.
Category
Medical Device
Distribution
25 states