Hazard

Biocompatibility recalls

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

What the numbers show

Total: 74
Critical: 0
Severe: 10
Most recent: 2020-11-11

Of the 74 biocompatibility recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (14%) 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 biocompatibility 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.

51–74 of 74

HighFDA (Devices)·Z-0339-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Prosthesis Components Due to Sterilant Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cup components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Due to Sterilant Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0385-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Acetabular Cups Due to Sterilant Concerns
Zimmer Biomet is recalling 412 hip prosthesis acetabular cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0382-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0357-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling specific acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Number: 00-8065-640-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0388-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components
Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0395-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm Number: 00-8065-954-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0392-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm Number: 00-8065-948-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0332-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0376-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components
Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0393-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm Number: 00-8065-950-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0593-2016·2016-01-13
Biomet 3i Dental Impression Copings Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling specific dental impression copings due to inadequate biocompatibility testing. The devices are distributed worldwide, including in the US.
Product
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abut
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0592-2016·2016-01-13
Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.
Product
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0594-2016·2016-01-13
Biomet 3i Recall Dental Impression Coping Kits for Biocompatibility Testing
Biomet 3i is recalling 30,111 Provide Impression Coping Kits worldwide due to inadequate biocompatibility testing.
Product
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0591-2016·2016-01-13
Biomet 3i Protection Caps Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling specific Protection Caps due to inadequate biocompatibility testing. The devices are distributed worldwide, including the US.
Product
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accesso
Category
Medical Device
Distribution
Distributed nationwide