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Terminated

All instrumentation associated with the Prelude PF Resurfacing Knee System.

FDA Recall Z-1318-2016 · Posted 2016-04-04

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKRR
Date Initiated2016-03-09
Date Terminated2017-05-23
Product Quantity576

Reason for Recall

Inadequate design control.

Firm Action

Zimmer Biomet sent an "Urgent Medical Device Recall Notice" dated March 9, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: 1. Immediately locate and remove the identified device(s) listed below from circulation. 2. Carefully follow the instructions on the enclosed Response Form. 3.Email a copy of the response form to CPW [email protected] prior to return of product. 4. Use priority carrier for your shipment. Please confirm receipt of this notice by sending back the response form within three (3) business days. Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root Cause

Device Design

Distribution Pattern

US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123907PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,Biomet Manufacturing Corp · 2013-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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