Data Foundry

Medical device recalls 2015

Recon — Class II medical device recall Z-2429-2015

Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-08-26. Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (ster

Recall numberZ-2429-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Howmedica Osteonics Corp., Mahwah, NJ, United States
Recall initiated2015-06-24
Classified2015-08-20
Reported by FDA2015-08-26
Terminated2016-04-29
Quantity16,992 total
Reason classessterility, packaging
Lot numbers109667-S2, 15892, 18295, 18296, 18374, 18378, 18387, 18500, 18566, 18567, 18568, 18574, 18697, 18705, 18706, 18753, 18754, 18794, 18795, 18796, 18837, 18839, 18845, 18846, 18847, 18855, 18872, 18873, 18874, 18885, 18886, 19061-S2, 19062-S2, 19064-S2, 19073-S2, 19099-S2, 19101-S2, 19111-S2, 19112-S2, 19605-S2 and 246 more
Model numbersRCN-S1, RCN-S2, RCN-S3, RCN-S4, RHA-S1, RHA-S2, RHA-S3, RHA-S4

Product

Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.

Reason for recall

Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

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-2429-2015. 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.