Use cautionMedical device recall · FDA · Published August 30, 2022
Synthes Hammertoe CCI Kit Recall: Drill Pin Incompatibility Risk
Synthes recalls Hammertoe CCI Kit (part 46.239.001) due to drill pin incompatibility with template causing surgical delays or soft tissue damage. Affected units sold with lot numbers MHC220119/MHC220120.
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
Take action
Contact the company
📍Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986
✎ GovInfoNow plain-language explainer
Synthes is recalling its Hammertoe Continuous Compression Implant (CCI) Kit (part number 46.239.001) because a packaging error means the drill pin doesn't fit the included drill template. This could delay surgery or cause soft tissue damage if a larger incision is needed. The risk also includes potential tissue reactions if the guide is used improperly. Read more at govinfonow.com/recall/60112-synthes-hammertoe-cci-kit-recall-drill-pin-incompatibility-risk.
“Synthes Hammertoe CCI Kit Recall: Drill Pin Incompatibility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60112-synthes-hammertoe-cci-kit-recall-drill-pin-incompatibility-risk. Based on FDA recall #Z-0008-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2023%22&limit=1).
The FDA announced on August 30, 2022, that Synthes (USA) Products LLC is recalling the Hammertoe Continuous Compression Implant Kit due to a packaging error. The hazard involves incompatible drill pins that may cause surgical delays or soft tissue damage.
According to the FDA, the drill bit is not compatible with the included drill template due to a packaging error. This incompatibility may result in surgical delay and potentially cause soft tissue damage if a larger incision is required. There is also a potential for adverse tissue reaction if plastic debris from a tight fit ends up in the wound.
Context
GovInfoNow's records show Synthes (USA) Products LLC has had 19 other recalls on record since July 21, 2017. Other recent recalls of similar products include Synthes Stardrive Screwdrivers May Cause Surgical Delay Recall (April 25, 2024), Synthes Low Prof Locking Screw Recall (September 26, 2025), and Synnes 2.4V TAP CORTEX SCREW Recall (February 25, 2026).
How to tell if you have this one
Check for the part number 46.239.001 on the kit. Affected units have lot numbers MHC220119 or MHC220120 and expire on June 1, 2027.
Brand
Synthes
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Compatibility
Verify the drill pin fits the included drill template before use; if not, do not proceed with surgery.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0008-2023 (August 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0008-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.