Active Articulation Dual Mobility Hip System recallZ-1025-2017 · Zimmer Biomet, Inc. · initiated Dec 19, 2016

Why it was recalled

Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.

FDA root cause category: Under Investigation by firm

What the company is doing

Zimmer Biomet sent an Urgent Medical Device Recall (REMOVAL) LOT SPECIFIC notifications dated December 19, 2016, to the affected distributors and Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected]. Distributor Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification

Recall details

Recall number

Z-1025-2017

Status

Terminated

Initiated by the company

Dec 19, 2016

Recalling firm

Zimmer Biomet, Inc.

Quantity

19

Product code

LPH

FDA submissions

K110555

Distribution

USA (nationwide) and Internationally to ARGENTINA

Product description

Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

Devices named in this recall

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

• Active Articulation™ Dual Mobility Hip System XL-200152

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 recall0 reports

Product lines

• Active Articulation Dual Mobility Hip SystemBiomet Orthopedics, LLC · 5 models · 7 reports · 1 recall

Other devices under the same FDA submission

15 devices cleared under K110555 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Active Articulation Hip System EP-200148

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  19 reports
• Active Articulation Hip System EP-200146

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  18 reports
• Active Articulation Hip System EP-200152

  Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  17 reports
• Active Articulation Hip System EP-200150

  Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  14 reports
• Active Articulation Hip System EP-200144

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  9 reports
• Active Articulation™ Dual Mobility Hip System XL-200150

  Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  3 reports
• Active Articulation 010000991

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  3 reports
• Active Articulation Hip System EP-200154

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• Active Articulation Hip System EP-200156

  Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  2 reports
• Active Articulation™ Dual Mobility Hip System XL-200156

  Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  2 reports
• Active Articulation Hip System EP-200160

  Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  1 report
• Active Articulation Hip System EP-200164

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 75970).

• Z-1024-2017 · Terminated
  RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223