Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large… — Class II medical device recall Z-1620-2013
Terminated recall by Zimmer, Inc., reported 2013-07-10, distributed nationwide. This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previou
| Recall number | Z-1620-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-05-23 |
| Classified | 2013-07-01 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2014-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, CN, KR |
| Reason classes | device malfunction |
| Lot numbers | 2010, 60768814, 60806551, 60893241, 60946820, 60999665, 61031668, 61110808, 61170678, 61205673, 61244194, 61392456, 61430127, 61588143, 61612276 |
| Model numbers | 00-4305-019-40, 430501940 |
Product
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Reason for recall
This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
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-1620-2013. 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.