All instrumentation associated with the Prelude PF Resurfacing Knee System.
FDA device recall Z-1318-2016 · posted 2016-04-04 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Inadequate design control.
- Action taken
- 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 ARFieldAction@zimmerbiomet.com 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
- Status
- Terminated
- Product code
- KRR
- Quantity affected
- 576
- Distribution
- US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
- Date initiated
- 2016-03-09
- Date posted
- 2016-04-04
- Date terminated
- 2017-05-23
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Prelude PF Patellae (K143543) | Biomet, Inc. | 2015-01-30 |
| PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, (K123907) | Biomet Manufacturing Corp | 2013-09-03 |