Hazard

Wrong Size Implant recalls

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

What the numbers show

Total: 10
Critical: 0
Severe: 1
Most recent: 2025-07-02

Of the 10 wrong size implant recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (10%) 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 wrong size implant 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.

1–10 of 10

HighFDA (Devices)·Z-2010-2025·2025-07-02
Altivate Reverse Torx Peripheral Screws Package Labeling Mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral screws because the package labeling lists a different screw size than what is actually included in the package.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2008-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
SevereFDA (Devices)·Z-1818-2025·2025-06-04
ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem
Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2024·2024-04-24
Conformis Identity Imprint PS Tibial Tray Size 4 Packaging Error
Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.
Product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2023·2023-04-26
Smith & Nephew Knee Implant Component Mispack: Wrong Size Distributed
Smith & Nephew is recalling 12 JOURNEY II UNI Tibia Insert components due to a manufacturing mispack. Some boxes incorrectly contain a different size component.
Product
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2021·2021-07-28
DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size
Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.
Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0064-2020·2019-10-16
Conformis Recalls iTotal Hip Replacement Stems Due to Packaging Error
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems because sizes 13 and 15 were packed in each other's packaging.
Product
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0980-2018·2018-03-21
Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching
Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers, creating a risk of using the wrong implant size.
Product
Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0111-2017·2016-10-26
Zimmer Biomet Recalls Vanguard Distal Femoral Augments Due to Labeling Error
Zimmer Biomet is recalling five Vanguard Distal Femoral Augments because the product inside the carton does not match the label. The mismatched size is easily identified during surgery.
Product
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Cor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2013·2013-08-07
SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments
SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.
Product
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal
Category
Medical Device
Distribution
4 states