—#168634

Product

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 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K112905
Affected lot / code info: All

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 surgical technique. Completing the Certification of Acknowledgement. Updated surgical techniques 1110.2-GLBL-en REV0818 and BMET0188.2 REV111218 for the Compress and Mini Compress systems are used, effective immediately, for surgeries that require the affected items. a. Access the full surgical techniques at www.zimmerbiomet.com by navigating to the Limb Salvage specialty and then Bone Compressive Devices under the Medical Professionals menu.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS

Timeline

Recall initiated: 2018-10-12
Terminated: 2020-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.