Pull Reduction Device For 4 — Class II medical device recall Z-1799-2015
Terminated recall by Synthes, Inc., reported 2015-06-24, distributed nationwide. Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardn
| Recall number | Z-1799-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-05-28 |
| Classified | 2015-06-15 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-08-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | device malfunction |
| Lot numbers | 1825699, 1825946, 1959344, 1959346, 3052800, 3066995, 3066996, 3066997, 3092693, 3092737, 3139434, 3139480, 3139483, 3139485, 3159152, 3167363, 3172147, 3207364, 3218030, 3218068, 3223545, 3224270, 3224271, 3224275, 3224581, 3224582, 3224583, 3233445, 3288206, 3422091, 3447606, 3469240, 3502469, 3535235, 3556421, 3556422, 3584316, 3642892, 3740917, 3740919 and 31 more |
| Model numbers | 03.120.023 |
Product
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
Reason for recall
Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
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-1799-2015. 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.