Data Foundry

Medical device recalls 2018

Part no — Class II medical device recall Z-2247-2018

Terminated recall by Synthes (USA) Products LLC, reported 2018-06-27, distributed in CA, IL, IN, KS, LA, MD, NC, NE…. Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Recall numberZ-2247-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSynthes (USA) Products LLC, West Chester, PA, United States
Recall initiated2018-03-05
Classified2018-06-15
Reported by FDA2018-06-27
Terminated2020-02-28
DistributedCA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, VA
Countries outside the USCA
Quantity3
Model numbers690.380

Product

Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set

Reason for recall

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

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-2247-2018. 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.