Synthes Oracle Spacer System Slap Hammer — Class II medical device recall Z-2282-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-10-02, distributed in CO, PA, TN, VA, WA. This recall is being initiated in response to complaints received where it was reported that the proximal end
| Recall number | Z-2282-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-01-11 |
| Classified | 2013-09-26 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2015-08-31 |
| Distributed | CO, PA, TN, VA, WA |
| Countries outside the US | CZ |
| Quantity | 27 |
| Lot numbers | 3723847, 6723847 |
| Model numbers | 03.809.690 |
Product
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
Reason for recall
This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke 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-2282-2013. 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.