Home › MPS Micro Precision Systems AG › Adjustable drill guide, Ø3.2 mm, 25° to 65°

Adjustable drill guide, Ø3.2 mm, 25° to 65°

MPS Micro Precision Systems AG · Model T5011 · UDI-DI 07640187913644

FZX Prescription

510(k) clearances

8,516

Adverse events (4 deaths)

Recalls

524

Facilities

Description

A hand-held re-usable surgical device designed to simultaneously direct the placement and angle of the drill hole and protect the surrounding tissue. It is cannulated to accept a dedicated drill bit size and has a serrated distal end to allow firm placement on the bone. The variable angle is from 25° to 65°.

Recalls

Date	Firm	Reason
2023-11-30	Waldemar Link GmbH & Co. KG (Mfg Site)	Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resec
2022-10-10	Hologic, Inc	IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
2019-08-21	Zimmer Biomet, Inc.	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
2019-08-21	Zimmer Biomet, Inc.	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
2019-08-21	Zimmer Biomet, Inc.	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
2018-03-26	Zimmer Biomet, Inc.	Potential failure of sterile packaging seal.
2017-08-07	Synthes, Inc.	May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is dr
2017-04-25	Cook Inc.	reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2016-08-09	Zimmer Biomet, Inc.	Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targ
2016-06-07	Synthes (USA) Products LLC	DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.