Vanguard Knee System recallZ-2183-2018 · Zimmer Biomet, Inc. · initiated May 11, 2018

Why it was recalled

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall (Removal)" letters dated 5/11/2018 to customers on 5/11/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: 1. Review this notification and ensure 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 Form to Zimmer Biomet. a. For each return, send a copy of Attachment 1 to [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returning product box(es) clearly with RECALL. 5. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts in accordance with local regulations. 6. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voice mail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

Recall details

Recall number

Z-2183-2018

Status

Terminated

Initiated by the company

May 11, 2018

Posted by the FDA

Jun 1, 2018

Recalling firm

Zimmer Biomet, Inc.

Quantity

169

Product code

JWH

FDA submissions

K113550, K171054

Distribution

Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.

Product description

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

Devices named in this recall

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

• VANGUARD KNEE SYSTEM 183621

  Biomet Orthopedics, LLC · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
  1 recall0 reports

Product lines

• Vanguard Knee SystemBiomet Orthopedics, LLC · 147 models · 306 reports · 13 recalls

Other devices under the same FDA submission

230 devices cleared under K113550, K171054 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• VANGUARD KNEE SYSTEM 184764

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 recalls5 reports
• Vanguard® Knee System 183108

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 recalls3 reports
• Vanguard® Knee System 183126

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 recalls3 reports
• Vanguard® Knee System 189082

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 recalls2 reports
• Vanguard® Knee System 183620

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall5 reports
• Vanguard® Knee System 183106

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall4 reports
• BIOMET KNEE SYSTEM 141215

  Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
  1 recall3 reports
• Vanguard® Knee System 183104

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall3 reports
• Vanguard® Knee System 183122

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall3 reports
• VANGUARD KNEE SYSTEM 184762

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall3 reports
• VANGUARD KNEE SYSTEM 184766

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall3 reports
• Vanguard® Knee System 183124

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall2 reports