Product 58 consists of all product under product code: HRS and same… — Class II medical device recall Z-1156-2016
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-1156-2016 |
|---|---|
| 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 | 119 |
| Reason classes | sterility |
| Lot numbers | 61771903, 61771908, 61771936, 61771950, 61859733, 61859738, 61879872, 61879874, 61879883, 61895477, 61895479, 61918348, 61941119, 61941121, 61944990, 61944992, 61944994, 61944995, 62049380, 62124572, 62124572N, 62134044, 62152982, 62180987, 62199039, 62233794, 62233795, 62233796, 62274946, 62274957, 62274957N, 62296602, 62296608, 62312399, 62312401, 62312401N, 62312402, 62312404, 62312404N |
| Model numbers | 234800904 |
Product
Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PROXIMAL DORSAL ULNA PLT 234801008 PROXIMAL DORSAL ULNA PLT 234801010 PROXIMAL DORSAL ULNA PLT 10H LT 234701304 PROXIMAL MEDIAL TIBIAL 4. 234701306 PROXIMAL MEDIAL TIBIAL 4. 234701308 PROXIMAL MEDIAL TIBIAL 4. 234701404 PROXIMAL MEDIAL TIBIAL 4. 234701406 PROXIMAL MEDIAL TIBIAL 4. 234701408 PROXIMAL MEDIAL TIBIAL 4. Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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-1156-2016. 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.