Z-1318-2016Class II

All instrumentation associated with the Prelude PF Resurfacing Knee System

Name: Z-1318-2016 All instrumentation associated with the Prelude PF Resurfacing Knee System
Creator: Biomet, Inc.
Published: 2016-03-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-03-09 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of All instrumentation associated with the Prelude PF Resurfacing Knee System on 2016-03-09. FDA classified it as Class II and gives the reason as "Inadequate design control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1318-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-09
Posted: 2016-04-04
Terminated: 2017-05-23
Recalling firm: Zimmer GmbH
Product: All instrumentation associated with the Prelude PF Resurfacing Knee System.
Product code: KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: Inadequate design control.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 576
Distribution: US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
Product codes and lots: All Lots of All Prelude PF instrumentation part numbers. Part Number Description 110004338: No. 1 Femoral Trial, Left 110004248: No. 1 Femoral Trial, Right 110004339: No. 2 Femoral Trial, Left 110004250: No. 2 Femoral Trial, Right 110004344: No. 3 Femoral Trial, Left 110004252: No. 3 Femoral Trial, Right 110004342: No. 4 Femoral Trial, Left 110004254: No. 4 Femoral Trial, Right 110004341: No. 5 Femoral Trial, Left 110004256: No. 5 Femoral Trial, Right 110004337: No. 6 Femoral Trial, Left 110004258: No. 6 Femoral Trial, Right 110004340: No. 6W Femoral Trial, Left 110004260: No. 6W Femoral Trial, Right 110004343: No. 7W Femoral Trial, Left 110004262: No. 7W Femoral Trial, Right 110004345: No. 8W Femoral Trial, Left 110004264: No. 8W Femoral Trial, Right 110004105: No. 1 Drill Guide, Left 110004106: No. 1 Drill Guide, Right 110004107: No. 2 Drill Guide, Left 110004108: No. 2 Drill Guide, Right 110004109: No. 3 Drill Guide, Left 110004110: No. 3 Drill Guide, Right 110004111: No.4 Drill Guide, Left 110004112: No.4 Drill Guide, Right 110004113: No. 5 Drill Guide, Left 110004114: No. 5 Drill Guide, Right 110004115: No. 6 Drill Guide, Left 110004116: No. 6 Drill Guide, Right 110004117: No. 6W Drill Guide, Left 110004118: No. 6W Drill Guide, Right 110004119: No. 7W Drill Guide, Left 110004120: No. 7W Drill Guide, Right 110004121: No. 8W Drill Guide, Left 110004122: No. 8W Drill Guide, Right 010001763: 25MM Reamer 010001768: 31MM Reamer 110004151: 25MM Stop Collar 110004165: 31MM Stop Collar 110007428: Stop Collar Push Button 110004170: 2.1MM Guide Pin 110004169: Trial Remover 110004172: Impactor Handle 110007398: 15 Degree Rasp 597004: Instrument Case 110018820: 25MM Peek Bushing 110018821: 31MM Peek Bushing

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1318-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1318-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-04

Product code KRR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)