Product 8 consists of all products under product code HWC — Class II medical device recall Z-1106-2016
Terminated recall by Zimmer Manufacturing B.V., reported 2016-03-23, distributed nationwide. As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Aug
| Recall number | Z-1106-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., Mercedita, PR, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-03-12 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 99 |
| Reason classes | sterility |
| Lot numbers | 61614768, 61888124, 61892658, 61892659, 61894346, 61894347, 62036752, 62036753, 62036754 |
| Model numbers | 3.5MM, 47483501201 |
Product
Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN 47483507501 3.5MM CORT. SCREW 75MM LN Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Reason for recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
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-1106-2016. 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.