Data Foundry

Medical device recalls 2013

NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia — Class II medical device recall Z-0459-2014

Terminated recall by Zimmer, Inc., reported 2013-12-18, distributed nationwide. This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have

Recall numberZ-0459-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer, Inc., Warsaw, IN, United States
Recall initiated2013-11-19
Classified2013-12-06
Reported by FDA2013-12-18
Terminated2015-05-06
DistributedNationwide (US)
Countries outside the USAE, AU, BE, CA, CH, DE, DK, EC, ES, GB, IN, IT, JP, KR, MX, MY, NL, PE, SG, ZA
Quantity625 units
Model numbers00-5879-067-26

Product

NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.

Reason for recall

This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0459-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.