RINGLOC BI-POLAR HIP SYSTEM recallZ-0097-2021 · Biomet, Inc. · initiated Sep 3, 2020

Why it was recalled

Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

FDA root cause category: Process control

What the company is doing

All affected customers were sent a letter on 09/03/2020 stating the following : Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. Zimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the required certification form or provided surgeon and hospital information/confirmation. 100% of the delivery notifications will be accounted for. An inventory return certification form will be returned from each distributor that certifies that all available products from their territory have been returned or accounted for. Affected products that are not returned or accounted for will be considered as "not in inventory and unavailable for return." Zimmer Biomet will deem accounts unresponsive after 3 effectiveness checks if there continues to be no response are making reasonable efforts. Product that has not been recovered rom unresponsive consignees will be reported as unaccounted for. Product returned from the field will be scrapped.

Recall details

Recall number

Z-0097-2021

Status

Terminated

Initiated by the company

Sep 3, 2020

Posted by the FDA

Oct 9, 2020

Recalling firm

Biomet, Inc.

Quantity

48 devices

Product code

JDI

FDA submissions

K051569

Distribution

Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field subject to removal.

Product description

(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• RINGLOC BI-POLAR HIP SYSTEM 11-165206

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 recalls3 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165228

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 recall1 death12 reports

Product lines

• RINGLOC BI-POLAR HIP SYSTEMBiomet Orthopedics, LLC · 16 models · 100 reports · 3 recalls

Other devices under the same FDA submission

14 devices cleared under K051569 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• RINGLOC BI-POLAR HIP SYSTEM 11-165218

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 recall2 deaths9 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165212

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 death12 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165226

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 death10 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165214

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 death9 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165232

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  8 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165224

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  7 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165222

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 death6 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165208

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  6 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165216

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  5 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165210

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  4 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165230

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  3 reports
• RINGLOC BI-POLAR HIP SYSTEM 11-165236

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports