Recall record at a glance
| Official record | Z-1799-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Synthes, Inc. |
| Report date | Jun 24, 2015 |
| Recall initiation date | May 28, 2015 |
| Quantity | 3747 US, 19 Foreign |
| Location | West Chester, PA, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
Worldwide Distribution-US (nationwide) and internationlly to Canada
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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