CPT Modular Stem — Class II medical device recall Z-0060-2013
Terminated recall by Zimmer, Inc., reported 2012-10-24, distributed nationwide. Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-80
| Recall number | Z-0060-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-09-13 |
| Classified | 2012-10-15 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2014-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BG, BR, DE, EG, GB, IN, MY, TH |
| Quantity | 59 both |
| Lot numbers | 61947708 |
| Model numbers | 00-8011-001-00 |
Product
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Reason for recall
Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.
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-0060-2013. 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.