AperFix Femoral Implant Coring Removal Drill — Class II medical device recall Z-2548-2018
Terminated recall by Cayenne Medical Inc., reported 2018-08-01, distributed nationwide. A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/o
| Recall number | Z-2548-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cayenne Medical Inc., Scottsdale, AZ, United States |
| Recall initiated | 2010-04-28 |
| Classified | 2018-07-25 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DK, FI, MY, NL, PL, TR |
| Quantity | 1,444 units |
| Reason classes | device malfunction |
| Lot numbers | 10130801, 10140904, 10140905, 10140906, 10160804, 10160901, 10160902, 10160903, 10211001, 10211004, 10211005, 10211010, 10211011, 10211013, 11071104, 11090904, 11091001, 11091002, 11091003, 11161015, 11161022, 11171015, 11171022, 1130905, 1130906, 1130907, 12030901, 12030902, 12030903, 12080802, 12090903, 12131001, 12131002, 12131003, 12131004, 12131005, 12171118, 12281001, 12281002, 12290910 and 143 more |
| Model numbers | CM-7109, CM-7110, CM-7111, CM-7129, CM-7130, CM-7131 |
Product
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
Reason for recall
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
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-2548-2018. 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.