Z-0669-2018Class II

LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for...

Name: Z-0669-2018 LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for...
Creator: Synthes, Inc.
Published: 2017-08-07
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2017-08-07 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments on 2017-08-07. FDA classified it as Class II and gives the reason as "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 drilled without the drill sleeve, the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0669-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Posted: 2018-02-21
Terminated: 2018-07-25
Recalling firm: Synthes GmbH
Product: LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Product code: FZX Guide, Surgical, Instrument
Reason for recall: 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 drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: In August of 2017 customers were mailed an URGENT FIELD SAFETY NOTICE titled "884115 - Locking Compression Plate (LCP) Drill Sleeve" requesting that customers who received product subject to recall to please contact: [email protected] or call 610-719-5450. In the event that you have product requiring use: Pre-assemble the drill sleeve with the plate preoperatively. If you experience difficulty connecting the drill sleeve to the plate, use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: o Align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. o If the drill hole must be used and no option to lock remains, a non-locking screw can be used.
Quantity in commerce: 567 units
Distribution: Distribution to US, Canada, and Germany.
Product codes and lots: Lot numbers FT00227 9972971 H028400 H161606 H288454

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0669-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0669-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)