MAYFIELD¿ Composite Series Base Unit Standard — Class II medical device recall Z-0869-2013
Terminated recall by Integra LifeSciences Corp., reported 2013-02-27, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Integra determined there is a possibility that the Base Units may break during use.
| Recall number | Z-0869-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2012-12-21 |
| Classified | 2013-02-21 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2013-07-10 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI |
| Countries outside the US | BE |
| Quantity | 96 units |
| Reason classes | device malfunction |
| Serial numbers | SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049 and 71 more |
| Model numbers | A3101 |
Product
MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
Reason for recall
Integra determined there is a possibility that the Base Units may break during use.
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-0869-2013. 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.