Z-0362-2008

VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model...

Name: Z-0362-2008 VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model...
Creator: Plus Orthopedics USA
Published: 2006-11-27
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2006-11-27 / Terminated / root cause: manufacturing process

FDA source

Plus Orthopedics USA began a recall of VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left... on 2006-11-27. The reason FDA records is "The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0362-2008
Status: Terminated
Initiated: 2006-11-27
Posted: 2007-12-08
Terminated: 2007-12-13
Recalling firm: Plus Orthopedics
Product: VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The initial depth of the withdrawal action taken November 2006 was to the distributor (agent) level. On 11/27/2006 Plus Orthopedics USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. Agents were notified by telephone to check their inventory and return any affected units. A telephone script was used.
Quantity in commerce: 19
Distribution: Nationwide to : AZ, CA, CO, FL, ID, NE, NY, SC, TX, UT, VA, and WA
Product codes and lots: Model Numbers/Lot Codes: 1214331/EM.1 and EM.6, 1214332/EM.1 and EM.6, 1214333/EM.1, 1214334/EM.5, and 1214335/EM.1

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)