Recall Z-0642-2019 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Zimmer Biomet, Inc.
Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 1785
| Date | Oct 12, 2018 |
| Status | Terminated |
| Reason | Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins. |
| Root cause | Device Design |
| Action | Zimmer notified accounts on 12/13/18 via email and FedEx (both original and expanded accounts) as a follow up to the medical device correction notification dated October 12, 2018. Zimmer Biomet identified additional item numbers that are within the scope of this issue. . Distributors letter identify the issue and their responsibilities, which include: Reviewing the correction notification and ensuring affected team members are aware of the contents. Offering assistance in ensuring users are aware of the updated surgical technique and how to locate it. Destroying previous copies of the surgic |
| Quantity | 323 devices US; 208 distributed OUS |
| Distribution | Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM Biomet Orthopedics, LLC, May 24, 2012 |