Z-2777-2020Class II

Peri-Loc Targeter 4.5Mm Distal Femur, Handle, Left, Non-Sterile -

Name: Z-2777-2020 Peri-Loc Targeter 4.5Mm Distal Femur, Handle, Left, Non-Sterile -
Creator: Smith & Nephew, Inc.
Published: 2020-06-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-06-29 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic... on 2020-06-29. FDA classified it as Class II and gives the reason as "The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part". 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-2777-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-29
Posted: 2020-08-10
Terminated: 2022-02-18
Recalling firm: Smith & Nephew, Inc.
Product: PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm sent a letter to customers dated 06/29/2020 and titled "Urgent Medical Device Recall Notice". The letter informs customers of a field action to voluntarily remove a single lot of PeriLoc Targeters due to a manufacturing error. Customers should inspect their inventory and locate any devices from the listed product and batch numbers enclosed with the Recall Notice, and quarantine them immediately. Sales reps or distributors, should notify customers of the field action and ensure that the required actions are complete. Customers should completed a form identifying if they have product to return or no product to return. Customers returning product should list batches and quantities that are being returned. Completed forms should be signed and send to [email protected]. The firm's contact information: [email protected]. T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)
Quantity in commerce: 3 units
Distribution: U.S Nationwide including in the states of IN and TN.
Product codes and lots: Product Number: 71173400, Lot Number: 16GM20026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2777-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2777-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-10

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)