RingLoc Hip System recallZ-1087-2019 · Zimmer Biomet, Inc. · initiated Mar 1, 2019

Why it was recalled

Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

FDA root cause category: Packaging process control

What the company is doing

Zimmer Biomet conducted recall by letter dated 3/1/19 to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors via email. Hospital risk managers and surgeons, as well as distributors with product notified Fed'x. Accounts asked to review notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory.3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.a. Complete Attachment 1 Inventory Return Certification Form. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Recall details

Recall number

Z-1087-2019

Status

Terminated

Initiated by the company

Mar 1, 2019

Recalling firm

Zimmer Biomet, Inc.

Quantity

809 units total

Product code

JWH

FDA submissions

K912245

Distribution

Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE

Product description

Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

Devices named in this recall

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

• RingLoc® Hip System 103533

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 recall4 reports

Product lines

• RingLoc Hip SystemBiomet Orthopedics, LLC · 40 models · 53 reports · 3 recalls

Other devices under the same FDA submission

8 devices cleared under K912245 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• RingLoc® Hip System 103531

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  1 recall0 reports
• Biomet® Knee System 141205

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  14 reports
• RingLoc® Hip System 103538

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  2 reports
• RingLoc® Hip System 103532

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• RingLoc® Hip System 103536

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• RingLoc® Hip System 103535

  Biomet Orthopedics, LLC · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report
• RingLoc® Hip System 103534

  Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 death1 report
• RingLoc® Hip System 103537

  Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 82332).

• Z-1086-2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant